Primary Familial Dilated Cardiomyopathy
Conditions
Keywords
Primary dilated cardiomyopathy (DCM), Familial dilated cardiomyopathy (DCM), Myosin Heavy Chain 7 (MYH7), Titin (TTN), MYK-491, danicamtiv
Brief summary
The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities.
Interventions
DRUGdanicamtiv
Myosin activator
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* For MYH7 and TTN cohorts, must have diagnosis of primary DCM (dilated cardiomyopathy), clinically stable and due to probably disease-causing variant of MYH7 or TTN * Has adequate acoustic windows for echocardiography * Maximum of 3 family members with same variant can be enrolled * For the cohort of primary DCM due to causalities other than MYH7 and TTN, participant must have diagnosis of primary DCM with a cause not related to MYH7 or TTN variants
Exclusion criteria
* Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s) * Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics) * Presence of protocol specified laboratory abnormalities at Screening * Recent acute coronary syndrome or angina pectoris (\<90 days) * Recent hospitalization for heart failure (\<90 days)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. |
| Number of Participants With Serious Adverse Events (SAEs) in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. |
| Number of Participants With Safety Laboratory Assessments by Intensity in Part A | From first dose to 14 days post last dose (Up to approximately 13 weeks) | Number of participants with safety laboratory assessments by intensity. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities. |
| Number of Participants With Clinically Significant Changes in Physical Examinations in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | Number of participants with clinically significant changes in physical examinations. |
| Number of Participants With Clinically Significant Changes in Vital Signs in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | Number of participants with clinically significant changes in vital signs. |
| Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A | From first dose to 30 days post last dose (Up to approximately 15 weeks) | Number of participants with clinically significant changes in 12-lead ECG recordings. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | From first dose to 14 days post last dose (Up to approximately 13 weeks) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities. Severe= An event preventing normal everyday activities. (An AE that is assessed as severe should not be confused with a SAE. Severe is a category utilized for rating the intensity of an event; and both AEs and SAEs can be assessed as severe.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. Higher LAFI values are considered better left atrial function while lower LFAI values may indicate left atrial dysfunction. |
| Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
| Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination | Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. |
Countries
Germany, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Part B will commence after a participant completes Part A and opts to continue onto Part B. Individual participant doses for Part B will be based on systolic ejection time increase in Part A.
Participants by arm
| Arm | Count |
|---|---|
| Part A - MYH7 - MYK-491 Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period | 12 |
| Part A - TTN - MYK-491 Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period | 14 |
| Part A - DCM-Genetic - MYK-491 Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period | 5 |
| Part A - DCM-Non Genetic - MYK-491 Participants with dilated cardiomyopathy (DCM)-Non genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period | 10 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Part A | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B | Adverse Event | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Part B | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Part B | Study terminated by sponsor | 0 | 0 | 0 | 0 | 7 | 5 | 3 |
| Part B | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Part A - MYH7 - MYK-491 | Part A - TTN - MYK-491 | Part A - DCM-Genetic - MYK-491 | Part A - DCM-Non Genetic - MYK-491 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 12 Participants | 4 Participants | 9 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 13 Participants | 3 Participants | 10 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Uknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 14 Participants | 5 Participants | 8 Participants | 38 Participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 2 Participants | 2 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 3 Participants | 8 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 | 0 / 5 | 0 / 10 | 0 / 12 | 0 / 14 | 0 / 4 | 0 / 9 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 4 | 0 / 4 | 0 / 1 | 0 / 5 | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 5 / 12 | 3 / 14 | 1 / 5 | 2 / 10 | 5 / 12 | 5 / 14 | 2 / 4 | 2 / 9 | 0 / 1 | 0 / 1 | 1 / 1 | 3 / 4 | 3 / 4 | 0 / 1 | 5 / 5 | 4 / 4 | 2 / 3 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 | 0 / 5 | 0 / 10 | 0 / 12 | 0 / 14 | 0 / 4 | 0 / 9 | 0 / 1 | 0 / 1 | 0 / 1 | 1 / 4 | 1 / 4 | 0 / 1 | 0 / 5 | 2 / 4 | 1 / 3 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) in Part A
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Population: All treated participants in Part A as pre-specified in protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A - MYH7 - MYK-491 | Number of Participants With Adverse Events (AEs) in Part A | 9 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Adverse Events (AEs) in Part A | 9 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Adverse Events (AEs) in Part A | 4 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Adverse Events (AEs) in Part A | 4 Participants |
Primary
Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A
Number of participants with clinically significant changes in 12-lead ECG recordings.
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Population: All treated participants in Part A as pre-specified in protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A - MYH7 - MYK-491 | Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A | 0 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes in Physical Examinations in Part A
Number of participants with clinically significant changes in physical examinations.
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Population: All treated participants in Part A as pre-specified in protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A - MYH7 - MYK-491 | Number of Participants With Clinically Significant Changes in Physical Examinations in Part A | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Clinically Significant Changes in Physical Examinations in Part A | 1 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Clinically Significant Changes in Physical Examinations in Part A | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Clinically Significant Changes in Physical Examinations in Part A | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes in Vital Signs in Part A
Number of participants with clinically significant changes in vital signs.
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Population: All treated participants in Part A as pre-specified in protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A - MYH7 - MYK-491 | Number of Participants With Clinically Significant Changes in Vital Signs in Part A | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Clinically Significant Changes in Vital Signs in Part A | 0 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Clinically Significant Changes in Vital Signs in Part A | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Clinically Significant Changes in Vital Signs in Part A | 0 Participants |
Primary
Number of Participants With Safety Laboratory Assessments by Intensity in Part A
Number of participants with safety laboratory assessments by intensity. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities.
Time frame: From first dose to 14 days post last dose (Up to approximately 13 weeks)
Population: All treated participants in Part A as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A - MYH7 - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Alanine aminotransferase increased Mild | 1 Participants |
| Part A - MYH7 - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Aspartate aminotransferase increased Mild | 1 Participants |
| Part A - MYH7 - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Blood creatinine increased Moderate | 0 Participants |
| Part A - MYH7 - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Fibrin D dimer increased Moderate | 0 Participants |
| Part A - MYH7 - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Hyperkalaemia Moderate | 0 Participants |
| Part A - MYH7 - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Hyperkalaemia Mild | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Blood creatinine increased Moderate | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Alanine aminotransferase increased Mild | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Hyperkalaemia Moderate | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Aspartate aminotransferase increased Mild | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Fibrin D dimer increased Moderate | 1 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Hyperkalaemia Mild | 1 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Hyperkalaemia Moderate | 1 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Alanine aminotransferase increased Mild | 1 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Aspartate aminotransferase increased Mild | 1 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Blood creatinine increased Moderate | 1 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Fibrin D dimer increased Moderate | 0 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Hyperkalaemia Mild | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Blood creatinine increased Moderate | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Hyperkalaemia Moderate | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Hyperkalaemia Mild | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Aspartate aminotransferase increased Mild | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Alanine aminotransferase increased Mild | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Safety Laboratory Assessments by Intensity in Part A | Fibrin D dimer increased Moderate | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) in Part A
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event.
Time frame: From first dose to 30 days post last dose (Up to approximately 15 weeks)
Population: All treated participants in Part A as pre-specified in protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A - MYH7 - MYK-491 | Number of Participants With Serious Adverse Events (SAEs) in Part A | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Serious Adverse Events (SAEs) in Part A | 0 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Serious Adverse Events (SAEs) in Part A | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Serious Adverse Events (SAEs) in Part A | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities. Severe= An event preventing normal everyday activities. (An AE that is assessed as severe should not be confused with a SAE. Severe is a category utilized for rating the intensity of an event; and both AEs and SAEs can be assessed as severe.)
Time frame: From first dose to 14 days post last dose (Up to approximately 13 weeks)
Population: All treated participants in Part A as pre-specified in protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A - MYH7 - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Mild | 8 Participants |
| Part A - MYH7 - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Moderate | 0 Participants |
| Part A - MYH7 - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Severe | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Mild | 6 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Severe | 0 Participants |
| Part A - TTN - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Moderate | 1 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Mild | 3 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Severe | 0 Participants |
| Part A - DCM-Genetic - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Moderate | 1 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Mild | 4 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Severe | 0 Participants |
| Part A - DCM-Non Genetic - MYK-491 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A | Moderate | 0 Participants |
Secondary
Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | Early termination | -0.90 E/E prime ratio | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | End of treatment period 1 | -2.45 E/E prime ratio | Standard Deviation 3.16 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | End of treatment period 2 | -2.15 E/E prime ratio | Standard Deviation 2.88 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | End of treatment period 2 | 0.45 E/E prime ratio | Standard Deviation 2.99 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | End of treatment period 1 | 0.07 E/E prime ratio | Standard Deviation 3.67 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | End of treatment period 1 | -0.20 E/E prime ratio | Standard Deviation 4.46 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | End of treatment period 2 | -2.16 E/E prime ratio | Standard Deviation 3.92 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | End of treatment period 2 | 1.03 E/E prime ratio | Standard Deviation 2.6 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | End of treatment period 1 | 0.41 E/E prime ratio | Standard Deviation 3.23 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 6 | -1.19 E/E prime ratio | Standard Deviation 4.09 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | Early termination | -1.07 E/E prime ratio | Standard Deviation 3.3 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 2 | -1.43 E/E prime ratio | Standard Deviation 4.37 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 12 | -2.24 E/E prime ratio | Standard Deviation 1.56 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 24 | 0.07 E/E prime ratio | Standard Deviation 4.67 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 48 | -4.88 E/E prime ratio | Standard Deviation 2.38 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 12 | -0.47 E/E prime ratio | Standard Deviation 3.85 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | Early termination | -0.51 E/E prime ratio | Standard Deviation 3.91 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 48 | -1.00 E/E prime ratio | Standard Deviation 3.89 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 24 | -0.66 E/E prime ratio | Standard Deviation 4.24 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 6 | -0.15 E/E prime ratio | Standard Deviation 5.41 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 2 | -0.03 E/E prime ratio | Standard Deviation 4.4 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 36 | 10.70 E/E prime ratio | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | Early termination | -0.03 E/E prime ratio | Standard Deviation 0.93 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 2 | -0.03 E/E prime ratio | Standard Deviation 0.47 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 6 | 1.25 E/E prime ratio | Standard Deviation 1.2 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline | week 12 | 0.60 E/E prime ratio | — |
Secondary
Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | Early termination | 0.20 E/E prime ratio | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | End of treatment period 1 | -1.29 E/E prime ratio | Standard Deviation 1.72 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | End of treatment period 2 | -1.14 E/E prime ratio | Standard Deviation 2.23 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | End of treatment period 2 | 0.12 E/E prime ratio | Standard Deviation 2.94 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | End of treatment period 1 | -0.08 E/E prime ratio | Standard Deviation 3.68 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | End of treatment period 1 | -1.80 E/E prime ratio | Standard Deviation 5.6 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | End of treatment period 2 | -3.58 E/E prime ratio | Standard Deviation 4.88 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | End of treatment period 2 | 0.73 E/E prime ratio | Standard Deviation 3.93 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | End of treatment period 1 | -0.49 E/E prime ratio | Standard Deviation 3.94 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 6 | -0.75 E/E prime ratio | Standard Deviation 4.23 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | Early termination | -0.91 E/E prime ratio | Standard Deviation 3.39 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 2 | -1.07 E/E prime ratio | Standard Deviation 2.88 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 12 | -2.17 E/E prime ratio | Standard Deviation 2.45 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 24 | -0.45 E/E prime ratio | Standard Deviation 3.99 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 48 | -4.08 E/E prime ratio | Standard Deviation 3.06 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 12 | 2.48 E/E prime ratio | Standard Deviation 5.43 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | Early termination | 0.75 E/E prime ratio | Standard Deviation 5.92 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 48 | -1.47 E/E prime ratio | Standard Deviation 1.44 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 24 | -0.47 E/E prime ratio | Standard Deviation 2.94 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 6 | -1.34 E/E prime ratio | Standard Deviation 2.15 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 2 | -1.00 E/E prime ratio | Standard Deviation 1.98 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 36 | 5.00 E/E prime ratio | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | Early termination | 0.10 E/E prime ratio | Standard Deviation 0.62 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 2 | 0.77 E/E prime ratio | Standard Deviation 1.42 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 6 | 1.80 E/E prime ratio | Standard Deviation 2.55 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline | week 12 | 4.00 E/E prime ratio | — |
Secondary
Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | Early termination | -2.00 E/E prime ratio | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | End of treatment period 1 | -3.12 E/E prime ratio | Standard Deviation 4.51 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | End of treatment period 2 | -1.45 E/E prime ratio | Standard Deviation 2.14 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | End of treatment period 2 | 0.07 E/E prime ratio | Standard Deviation 4 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | End of treatment period 1 | -0.91 E/E prime ratio | Standard Deviation 3.78 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | End of treatment period 1 | 0.65 E/E prime ratio | Standard Deviation 2.89 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | End of treatment period 2 | -1.38 E/E prime ratio | Standard Deviation 2.82 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | End of treatment period 2 | 1.32 E/E prime ratio | Standard Deviation 3.07 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | End of treatment period 1 | 1.86 E/E prime ratio | Standard Deviation 2.3 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 6 | -1.27 E/E prime ratio | Standard Deviation 4.43 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | Early termination | -1.19 E/E prime ratio | Standard Deviation 3.67 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 2 | -1.77 E/E prime ratio | Standard Deviation 6.75 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 12 | -2.27 E/E prime ratio | Standard Deviation 3.53 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 24 | 0.70 E/E prime ratio | Standard Deviation 5.41 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 48 | -5.68 E/E prime ratio | Standard Deviation 4.89 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 12 | -1.30 E/E prime ratio | Standard Deviation 3.68 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | Early termination | -1.19 E/E prime ratio | Standard Deviation 4.95 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 48 | 0.05 E/E prime ratio | Standard Deviation 7.37 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 24 | -2.03 E/E prime ratio | Standard Deviation 7.68 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 6 | 1.33 E/E prime ratio | Standard Deviation 10.61 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 2 | 1.50 E/E prime ratio | Standard Deviation 9.41 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 36 | 16.50 E/E prime ratio | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | Early termination | -0.27 E/E prime ratio | Standard Deviation 2.2 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 2 | -0.83 E/E prime ratio | Standard Deviation 1.57 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 6 | 0.65 E/E prime ratio | Standard Deviation 0.07 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline | week 12 | -2.70 E/E prime ratio | — |
Secondary
Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | Early termination | -7.060 Percent change | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | End of treatment period 1 | 5.617 Percent change | Standard Deviation 13.459 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | End of treatment period 2 | 15.504 Percent change | Standard Deviation 18.234 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | End of treatment period 2 | 9.870 Percent change | Standard Deviation 15.019 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | End of treatment period 1 | 4.675 Percent change | Standard Deviation 12.173 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | End of treatment period 2 | 8.102 Percent change | Standard Deviation 21.513 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | End of treatment period 1 | 2.687 Percent change | Standard Deviation 26.913 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | End of treatment period 2 | 9.655 Percent change | Standard Deviation 14.789 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | End of treatment period 1 | 2.489 Percent change | Standard Deviation 10.953 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 24 | 6.522 Percent change | Standard Deviation 23.635 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 48 | 23.815 Percent change | Standard Deviation 26.494 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | Early termination | -0.711 Percent change | Standard Deviation 30.276 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 2 | -1.903 Percent change | Standard Deviation 19.042 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 6 | -9.410 Percent change | Standard Deviation 20.95 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 12 | 5.089 Percent change | Standard Deviation 17.898 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 48 | 27.568 Percent change | Standard Deviation 24.279 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 36 | 2.595 Percent change | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 12 | 24.306 Percent change | Standard Deviation 30.693 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 2 | 15.609 Percent change | Standard Deviation 10.759 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 6 | 21.196 Percent change | Standard Deviation 24.108 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 24 | 19.181 Percent change | Standard Deviation 31.252 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | Early termination | 11.267 Percent change | Standard Deviation 25.412 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | Week 42 | 43.996 Percent change | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 2 | 1.058 Percent change | Standard Deviation 6.753 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 12 | -6.694 Percent change | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | Early termination | -6.924 Percent change | Standard Deviation 11.148 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline | week 6 | -7.265 Percent change | Standard Deviation 24.267 |
Secondary
Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. Higher LAFI values are considered better left atrial function while lower LFAI values may indicate left atrial dysfunction.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | Early termination | -11.0849 Index | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | End of treatment period 1 | 5.2299 Index | Standard Deviation 5.3847 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | End of treatment period 2 | 11.1434 Index | Standard Deviation 10.5287 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | End of treatment period 2 | 6.8482 Index | Standard Deviation 13.2805 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | End of treatment period 1 | 1.6645 Index | Standard Deviation 11.9891 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | End of treatment period 1 | -0.4600 Index | Standard Deviation 1.6721 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | End of treatment period 2 | 1.6243 Index | Standard Deviation 5.5803 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | End of treatment period 2 | 3.6366 Index | Standard Deviation 6.4861 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | End of treatment period 1 | 0.3524 Index | Standard Deviation 5.0864 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 6 | 0.7215 Index | Standard Deviation 23.0068 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | Early termination | 0.3925 Index | Standard Deviation 23.935 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 2 | 4.1989 Index | Standard Deviation 10.0937 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 12 | 5.3578 Index | Standard Deviation 14.5382 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 24 | -4.8648 Index | Standard Deviation 19.3724 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 48 | 6.3041 Index | Standard Deviation 18.4543 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 12 | 8.4149 Index | Standard Deviation 7.3469 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | Early termination | 2.4252 Index | Standard Deviation 10.4948 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 48 | 12.8222 Index | Standard Deviation 14.0703 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 24 | 8.1890 Index | Standard Deviation 8.8584 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 6 | 9.9039 Index | Standard Deviation 8.9999 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 2 | 5.6654 Index | Standard Deviation 7.6211 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 36 | 8.6083 Index | Standard Deviation 8.6083 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | Early termination | -20.4736 Index | Standard Deviation 4.7293 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 2 | -10.2619 Index | Standard Deviation 21.281 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 6 | 1.3624 Index | Standard Deviation 15.4676 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline | week 12 | -22.1266 Index | — |
Secondary
Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | Early termination | 8.1892 mL/m^2 | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | End of treatment period 1 | -0.6427 mL/m^2 | Standard Deviation 5.0007 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | End of treatment period 2 | -0.3419 mL/m^2 | Standard Deviation 4.2365 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | End of treatment period 2 | 1.1617 mL/m^2 | Standard Deviation 6.0815 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | End of treatment period 1 | 0.9860 mL/m^2 | Standard Deviation 7.1462 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | End of treatment period 1 | -0.6320 mL/m^2 | Standard Deviation 9.1208 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | End of treatment period 2 | -1.1870 mL/m^2 | Standard Deviation 7.2047 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | End of treatment period 2 | -0.2139 mL/m^2 | Standard Deviation 2.5533 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | End of treatment period 1 | -0.0084 mL/m^2 | Standard Deviation 2.4459 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 6 | 1.1887 mL/m^2 | Standard Deviation 4.2647 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | Early termination | -0.0097 mL/m^2 | Standard Deviation 6.8537 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 2 | 0.1346 mL/m^2 | Standard Deviation 6.4456 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 12 | -1.9834 mL/m^2 | Standard Deviation 9.0618 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 24 | -2.3145 mL/m^2 | Standard Deviation 11.3192 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 48 | -2.4524 mL/m^2 | Standard Deviation 3.4679 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 12 | -7.1717 mL/m^2 | Standard Deviation 14.8684 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | Early termination | -1.4975 mL/m^2 | Standard Deviation 9.7454 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 48 | -11.2887 mL/m^2 | Standard Deviation 15.6892 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 24 | -1.8423 mL/m^2 | Standard Deviation 17.85 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 36 | -13.3385 mL/m^2 | Standard Deviation 3.1173 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 6 | -5.5545 mL/m^2 | Standard Deviation 13.4164 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 2 | -0.1818 mL/m^2 | Standard Deviation 5.1802 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | Week 42 | -11.7208 mL/m^2 | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | Early termination | 6.5957 mL/m^2 | Standard Deviation 3.9106 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 2 | 2.3315 mL/m^2 | Standard Deviation 9.2253 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 6 | -0.5969 mL/m^2 | Standard Deviation 10.157 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline | week 12 | 7.8293 mL/m^2 | — |
Secondary
Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | Early termination | 12.030 mL | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | End of treatment period 1 | -2.545 mL | Standard Deviation 4.182 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | End of treatment period 2 | -3.985 mL | Standard Deviation 5.681 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | End of treatment period 2 | 0.049 mL | Standard Deviation 8.529 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | End of treatment period 1 | -0.374 mL | Standard Deviation 8.947 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | End of treatment period 1 | -3.663 mL | Standard Deviation 9.552 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | End of treatment period 2 | -3.993 mL | Standard Deviation 5.672 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | End of treatment period 2 | -2.866 mL | Standard Deviation 6.613 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | End of treatment period 1 | -0.563 mL | Standard Deviation 3.67 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 6 | 3.430 mL | Standard Deviation 9.313 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | Early termination | 1.313 mL | Standard Deviation 13.248 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 2 | 0.509 mL | Standard Deviation 11.279 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 12 | -3.409 mL | Standard Deviation 13.577 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 24 | -2.858 mL | Standard Deviation 16.826 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 48 | -7.560 mL | Standard Deviation 7.287 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 12 | -13.953 mL | Standard Deviation 24.798 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | Early termination | -4.793 mL | Standard Deviation 19.027 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 48 | -19.843 mL | Standard Deviation 24.404 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 24 | -5.214 mL | Standard Deviation 32.177 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 36 | -16.410 mL | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 6 | -10.938 mL | Standard Deviation 22.821 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 2 | -3.807 mL | Standard Deviation 9.917 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | Week 42 | -27.640 mL | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | Early termination | 10.607 mL | Standard Deviation 3.279 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 2 | 2.817 mL | Standard Deviation 8.224 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 6 | 1.680 mL | Standard Deviation 5.374 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline | week 12 | 9.950 mL | — |
Secondary
Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | End of treatment period 2 | 8.84 percentage | Standard Deviation 6.43 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | Early termination | -3.20 percentage | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | End of treatment period 1 | 4.78 percentage | Standard Deviation 7.4 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | End of treatment period 1 | 4.94 percentage | Standard Deviation 7.08 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | End of treatment period 2 | 5.94 percentage | Standard Deviation 6.15 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | End of treatment period 1 | -0.75 percentage | Standard Deviation 3.06 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | End of treatment period 2 | 1.37 percentage | Standard Deviation 5.36 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | End of treatment period 2 | 4.84 percentage | Standard Deviation 10 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | End of treatment period 1 | 2.47 percentage | Standard Deviation 6.14 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 48 | 3.85 percentage | Standard Deviation 4.75 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | Early termination | -2.94 percentage | Standard Deviation 4.65 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 12 | 2.44 percentage | Standard Deviation 5.39 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 2 | 5.53 percentage | Standard Deviation 10.31 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 6 | 3.31 percentage | Standard Deviation 5.85 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 24 | -2.78 percentage | Standard Deviation 0.59 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | Early termination | 3.99 percentage | Standard Deviation 9.55 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 6 | -0.40 percentage | Standard Deviation 7.83 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | Week 42 | 23.60 percentage | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 36 | 10.80 percentage | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 24 | 2.24 percentage | Standard Deviation 8.58 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 2 | 4.21 percentage | Standard Deviation 11.03 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 12 | 1.77 percentage | Standard Deviation 5.26 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 48 | 7.12 percentage | Standard Deviation 11.12 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 2 | 5.60 percentage | Standard Deviation 2.12 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 6 | 14.05 percentage | Standard Deviation 18.03 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | week 12 | 7.60 percentage | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline | Early termination | 4.13 percentage | Standard Deviation 5.87 |
Secondary
Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | End of treatment period 2 | 29.4 msec | Standard Deviation 31 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | End of treatment period 1 | 12.1 msec | Standard Deviation 23.7 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | Early termination | -23.0 msec | — |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | End of treatment period 2 | 29.0 msec | Standard Deviation 25.4 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | End of treatment period 1 | 7.4 msec | Standard Deviation 28.8 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | End of treatment period 1 | -3.5 msec | Standard Deviation 8.7 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | End of treatment period 2 | -5.6 msec | Standard Deviation 18.2 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | End of treatment period 1 | 3.3 msec | Standard Deviation 36.3 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | End of treatment period 2 | 15.2 msec | Standard Deviation 54.4 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | Early termination | 13.5 msec | Standard Deviation 44.4 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 2 | 38.3 msec | Standard Deviation 30 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 6 | 25.3 msec | Standard Deviation 22.3 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 12 | 32.1 msec | Standard Deviation 27.4 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 24 | 39.8 msec | Standard Deviation 46.3 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 48 | 42.3 msec | Standard Deviation 40.3 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 2 | 44.3 msec | Standard Deviation 16.3 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 48 | 30.3 msec | Standard Deviation 34 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | Early termination | -1.4 msec | Standard Deviation 20.5 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 12 | 38.2 msec | Standard Deviation 33.5 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 6 | 53.3 msec | Standard Deviation 43.6 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 24 | 59.8 msec | Standard Deviation 39.5 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 36 | 47.5 msec | Standard Deviation 9.2 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | Early termination | -14.3 msec | Standard Deviation 35.2 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 6 | 20.5 msec | Standard Deviation 67.2 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 2 | 20.3 msec | Standard Deviation 34.5 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline | week 12 | 44.0 msec | — |
Secondary
Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | End of treatment period 1 | -3.62 percentage | Standard Deviation 3.73 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | End of treatment period 2 | -4.00 percentage | Standard Deviation 3.17 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | Early termination | 0.40 percentage | — |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | End of treatment period 2 | -1.45 percentage | Standard Deviation 3.32 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | End of treatment period 1 | 0.58 percentage | Standard Deviation 2.83 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | End of treatment period 1 | -4.10 percentage | Standard Deviation 4.07 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | End of treatment period 2 | -2.08 percentage | Standard Deviation 1.25 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | End of treatment period 1 | 0.15 percentage | Standard Deviation 4.47 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | End of treatment period 2 | -0.78 percentage | Standard Deviation 3.87 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 12 | -3.80 percentage | Standard Deviation 1.26 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | Early termination | 0.54 percentage | Standard Deviation 5.5 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 2 | -5.16 percentage | Standard Deviation 4.55 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 6 | -4.07 percentage | Standard Deviation 3.43 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 24 | -2.64 percentage | Standard Deviation 4.72 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 48 | -4.05 percentage | Standard Deviation 3.13 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 6 | -4.68 percentage | Standard Deviation 1.11 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | Week 42 | -6.00 percentage | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | Early termination | -1.52 percentage | Standard Deviation 2.38 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 24 | -0.88 percentage | Standard Deviation 1.94 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 36 | -2.60 percentage | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 12 | -0.94 percentage | Standard Deviation 2.65 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 2 | -3.00 percentage | Standard Deviation 3.64 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 48 | -3.98 percentage | Standard Deviation 3.43 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | Early termination | 0.40 percentage | Standard Deviation 5.23 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 2 | -3.25 percentage | Standard Deviation 5.3 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 6 | -0.10 percentage | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline | week 12 | 0.00 percentage | — |
Secondary
Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | Early termination | -0.70 percentage | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | End of treatment period 2 | -2.05 percentage | Standard Deviation 2.05 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | End of treatment period 1 | -1.41 percentage | Standard Deviation 2.79 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | End of treatment period 2 | -1.21 percentage | Standard Deviation 2.23 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | End of treatment period 1 | -0.79 percentage | Standard Deviation 2.31 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | End of treatment period 2 | -1.92 percentage | Standard Deviation 2 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | End of treatment period 1 | -0.32 percentage | Standard Deviation 2.81 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | End of treatment period 2 | -0.95 percentage | Standard Deviation 2.46 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | End of treatment period 1 | -0.36 percentage | Standard Deviation 1.63 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 12 | -2.34 percentage | Standard Deviation 2.03 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 24 | 0.02 percentage | Standard Deviation 1.25 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 6 | -2.18 percentage | Standard Deviation 2.53 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 2 | -1.60 percentage | Standard Deviation 2.59 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | Early termination | 0.01 percentage | Standard Deviation 2.12 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 48 | -2.77 percentage | Standard Deviation 1.99 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 12 | -2.00 percentage | Standard Deviation 2.34 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 2 | -1.84 percentage | Standard Deviation 1.66 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 6 | -1.90 percentage | Standard Deviation 1.11 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 24 | -2.62 percentage | Standard Deviation 2.66 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 36 | -2.50 percentage | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | Week 42 | -7.70 percentage | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 48 | -4.33 percentage | Standard Deviation 1.3 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | Early termination | -1.31 percentage | Standard Deviation 1.41 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | Early termination | -1.90 percentage | Standard Deviation 1.81 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 6 | -3.65 percentage | Standard Deviation 0.49 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 12 | -4.00 percentage | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline | week 2 | -1.80 percentage | Standard Deviation 2.63 |
Secondary
Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | Early termination | 0.650 mL | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | End of treatment period 1 | 10.581 mL | Standard Deviation 9.814 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | End of treatment period 2 | 10.151 mL | Standard Deviation 19.585 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | End of treatment period 1 | 5.628 mL | Standard Deviation 3.127 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | End of treatment period 2 | 1.243 mL | Standard Deviation 14.275 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | End of treatment period 2 | 1.050 mL | Standard Deviation 13.379 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | End of treatment period 1 | 1.855 mL | Standard Deviation 7.979 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | End of treatment period 1 | -5.897 mL | Standard Deviation 17.237 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | End of treatment period 2 | 2.172 mL | Standard Deviation 20 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 2 | 15.576 mL | Standard Deviation 11.932 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 24 | 13.893 mL | Standard Deviation 14.892 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | Early termination | 2.684 mL | Standard Deviation 30.133 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 48 | 19.070 mL | Standard Deviation 16.317 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 12 | 19.410 mL | Standard Deviation 21.832 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 6 | 7.778 mL | Standard Deviation 21.508 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 48 | -6.863 mL | Standard Deviation 12.464 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 2 | -7.600 mL | Standard Deviation 14.358 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 6 | 18.313 mL | Standard Deviation 14.697 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 12 | 24.853 mL | Standard Deviation 18.181 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 36 | -20.450 mL | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 24 | 25.174 mL | Standard Deviation 24.052 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | Early termination | -11.136 mL | Standard Deviation 14.539 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | Early termination | 5.533 mL | Standard Deviation 20.941 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 2 | -15.678 mL | Standard Deviation 18.882 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 12 | 22.320 mL | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline | week 6 | 16.500 mL | — |
Secondary
Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | Early termination | 0.70 E/A ratio | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | End of treatment period 1 | 0.02 E/A ratio | Standard Deviation 0.16 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | End of treatment period 2 | -0.16 E/A ratio | Standard Deviation 0.4 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | End of treatment period 2 | -0.08 E/A ratio | Standard Deviation 0.37 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | End of treatment period 1 | -0.01 E/A ratio | Standard Deviation 0.32 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | End of treatment period 1 | -0.10 E/A ratio | Standard Deviation 0.1 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | End of treatment period 2 | -0.26 E/A ratio | Standard Deviation 0.54 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | End of treatment period 2 | -0.04 E/A ratio | Standard Deviation 0.15 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | End of treatment period 1 | 0.04 E/A ratio | Standard Deviation 0.11 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 6 | -0.25 E/A ratio | Standard Deviation 0.45 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | Early termination | -0.10 E/A ratio | Standard Deviation 0.32 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 2 | 0.07 E/A ratio | Standard Deviation 0.92 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 12 | -0.23 E/A ratio | Standard Deviation 0.5 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 24 | 0.00 E/A ratio | Standard Deviation 0.1 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 48 | -0.40 E/A ratio | Standard Deviation 0.52 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 12 | -0.76 E/A ratio | Standard Deviation 0.7 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | Early termination | -0.37 E/A ratio | Standard Deviation 0.52 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 48 | -0.77 E/A ratio | Standard Deviation 0.85 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 24 | -0.53 E/A ratio | Standard Deviation 0.78 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 6 | -0.58 E/A ratio | Standard Deviation 0.77 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 2 | -0.32 E/A ratio | Standard Deviation 0.4 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 36 | 0.20 E/A ratio | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | Early termination | 0.17 E/A ratio | Standard Deviation 0.06 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 2 | -0.12 E/A ratio | Standard Deviation 0.21 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 6 | 0.15 E/A ratio | Standard Deviation 0.21 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline | week 12 | 0.20 E/A ratio | — |
Secondary
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | Early termination | -0.60 cm/s | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | End of treatment period 1 | 0.55 cm/s | Standard Deviation 1.63 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | End of treatment period 2 | 0.51 cm/s | Standard Deviation 1.5 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | End of treatment period 2 | 0.58 cm/s | Standard Deviation 2.97 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | End of treatment period 1 | 0.37 cm/s | Standard Deviation 2.51 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | End of treatment period 1 | 1.23 cm/s | Standard Deviation 1.21 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | End of treatment period 2 | 2.60 cm/s | Standard Deviation 3.38 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | End of treatment period 2 | -0.66 cm/s | Standard Deviation 2.23 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | End of treatment period 1 | 0.46 cm/s | Standard Deviation 3.27 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 6 | 0.43 cm/s | Standard Deviation 1.18 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | Early termination | 0.20 cm/s | Standard Deviation 2.85 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 2 | 0.23 cm/s | Standard Deviation 2.77 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 12 | 0.83 cm/s | Standard Deviation 1.99 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 24 | 0.15 cm/s | Standard Deviation 1.52 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 48 | 2.25 cm/s | Standard Deviation 1.89 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 12 | -1.48 cm/s | Standard Deviation 2.36 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | Early termination | 0.37 cm/s | Standard Deviation 2.28 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 48 | -0.30 cm/s | Standard Deviation 1.6 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 24 | -0.40 cm/s | Standard Deviation 2.09 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 6 | -0.14 cm/s | Standard Deviation 1.29 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 2 | 0.42 cm/s | Standard Deviation 1.47 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 36 | -1.80 cm/s | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | Early termination | 2.23 cm/s | Standard Deviation 2.16 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 2 | -1.30 cm/s | Standard Deviation 1.51 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 6 | -1.30 cm/s | Standard Deviation 0.99 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline | week 12 | -3.20 cm/s | — |
Secondary
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | Early termination | 0.60 cm/s | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | End of treatment period 1 | 0.75 cm/s | Standard Deviation 1.66 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | End of treatment period 2 | -0.04 cm/s | Standard Deviation 0.86 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | End of treatment period 2 | 0.28 cm/s | Standard Deviation 1.59 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | End of treatment period 1 | 0.26 cm/s | Standard Deviation 1.62 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | End of treatment period 1 | -0.05 cm/s | Standard Deviation 1.35 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | End of treatment period 2 | 0.84 cm/s | Standard Deviation 1.12 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | End of treatment period 2 | -0.32 cm/s | Standard Deviation 1.32 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | End of treatment period 1 | -0.73 cm/s | Standard Deviation 1.3 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 6 | 0.58 cm/s | Standard Deviation 1.12 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | Early termination | 1.04 cm/s | Standard Deviation 1.65 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 2 | 0.51 cm/s | Standard Deviation 1.43 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 12 | 0.60 cm/s | Standard Deviation 1.16 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 24 | -0.65 cm/s | Standard Deviation 0.76 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 48 | 1.75 cm/s | Standard Deviation 1.32 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 12 | -0.86 cm/s | Standard Deviation 1.23 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | Early termination | 0.04 cm/s | Standard Deviation 1.25 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 48 | -1.50 cm/s | Standard Deviation 1.93 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 24 | -0.75 cm/s | Standard Deviation 0.91 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 6 | -0.73 cm/s | Standard Deviation 1.94 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 2 | -0.84 cm/s | Standard Deviation 1.52 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 36 | -5.10 cm/s | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | Early termination | 1.03 cm/s | Standard Deviation 2.58 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 2 | -0.17 cm/s | Standard Deviation 1.12 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 6 | -0.10 cm/s | Standard Deviation 2.97 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline | week 12 | 1.90 cm/s | — |
Secondary
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | Early termination | 3.60 mm | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | End of treatment period 1 | 0.48 mm | Standard Deviation 3.61 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | End of treatment period 2 | -0.85 mm | Standard Deviation 4.36 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | End of treatment period 2 | -3.12 mm | Standard Deviation 3.34 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | End of treatment period 1 | -2.49 mm | Standard Deviation 3.51 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | End of treatment period 1 | -0.60 mm | Standard Deviation 3.91 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | End of treatment period 2 | -3.50 mm | Standard Deviation 3.84 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | End of treatment period 2 | -1.77 mm | Standard Deviation 4.6 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | End of treatment period 1 | -1.37 mm | Standard Deviation 5.14 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 6 | -1.75 mm | Standard Deviation 3.34 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | Early termination | -1.97 mm | Standard Deviation 5.36 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 2 | -5.11 mm | Standard Deviation 9.22 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 12 | -2.09 mm | Standard Deviation 3.58 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 24 | -2.10 mm | Standard Deviation 2.5 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 48 | -3.40 mm | Standard Deviation 3.64 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 12 | -0.17 mm | Standard Deviation 2.64 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | Early termination | 0.46 mm | Standard Deviation 3.4 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 48 | -2.13 mm | Standard Deviation 3.4 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 24 | -2.86 mm | Standard Deviation 5.87 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 36 | -3.10 mm | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 6 | -3.10 mm | Standard Deviation 2.61 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 2 | -3.56 mm | Standard Deviation 4.03 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | Week 42 | -1.50 mm | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | Early termination | 2.70 mm | Standard Deviation 1.13 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 2 | -5.00 mm | Standard Deviation 7.04 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 6 | 0.30 mm | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline | week 12 | 0.90 mm | — |
Secondary
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | Early termination | -1.6197 m1/m2 | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | End of treatment period 1 | -7.3006 m1/m2 | Standard Deviation 7.0043 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | End of treatment period 2 | -4.3719 m1/m2 | Standard Deviation 11.6238 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | End of treatment period 2 | -4.4642 m1/m2 | Standard Deviation 12.9621 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | End of treatment period 1 | 0.4855 m1/m2 | Standard Deviation 10.8288 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | End of treatment period 1 | 1.3937 m1/m2 | Standard Deviation 3.981 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | End of treatment period 2 | -1.1050 m1/m2 | Standard Deviation 6.1575 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | End of treatment period 2 | -2.1417 m1/m2 | Standard Deviation 12.827 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | End of treatment period 1 | -3.6715 m1/m2 | Standard Deviation 8.4975 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 6 | -6.2694 m1/m2 | Standard Deviation 17.506 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | Early termination | -7.2323 m1/m2 | Standard Deviation 24.2148 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 2 | -19.7184 m1/m2 | Standard Deviation 31.0876 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 12 | -5.2247 m1/m2 | Standard Deviation 11.4301 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 24 | -5.9020 m1/m2 | Standard Deviation 20.7779 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 48 | -14.3351 m1/m2 | Standard Deviation 24.7973 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 12 | -11.7627 m1/m2 | Standard Deviation 17.1607 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | Early termination | -6.7050 m1/m2 | Standard Deviation 17.2581 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 48 | -18.5657 m1/m2 | Standard Deviation 6.0845 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 24 | -6.2700 m1/m2 | Standard Deviation 24.3104 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 36 | -13.0453 m1/m2 | Standard Deviation 5.3813 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 6 | -12.9208 m1/m2 | Standard Deviation 11.0202 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 2 | -6.7773 m1/m2 | Standard Deviation 10.3963 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | Week 42 | -11.8121 m1/m2 | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | Early termination | 8.3887 m1/m2 | Standard Deviation 3.3592 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 2 | 0.2596 m1/m2 | Standard Deviation 0.0152 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 6 | -11.4771 m1/m2 | Standard Deviation 18.4933 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline | week 12 | 7.4828 m1/m2 | — |
Secondary
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | End of treatment period 2 | -3.14 mm | Standard Deviation 5.97 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | End of treatment period 1 | -0.15 mm | Standard Deviation 4.07 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | Early termination | -1.50 mm | — |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | End of treatment period 2 | -5.48 mm | Standard Deviation 4.83 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | End of treatment period 1 | -2.84 mm | Standard Deviation 3.47 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | End of treatment period 2 | -3.60 mm | Standard Deviation 3.48 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | End of treatment period 1 | 0.10 mm | Standard Deviation 1.44 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | End of treatment period 1 | -1.77 mm | Standard Deviation 5.6 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | End of treatment period 2 | -2.20 mm | Standard Deviation 6.03 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 48 | 2.90 mm | Standard Deviation 7.07 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 2 | -0.90 mm | Standard Deviation 4.25 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 6 | -0.17 mm | Standard Deviation 6.01 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 12 | -0.92 mm | Standard Deviation 4.67 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 24 | -0.07 mm | Standard Deviation 6.04 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | Early termination | 1.33 mm | Standard Deviation 10.57 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 6 | -5.93 mm | Standard Deviation 4.76 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 24 | -6.12 mm | Standard Deviation 4.18 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 36 | -5.80 mm | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 2 | -5.94 mm | Standard Deviation 3.74 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 48 | -4.90 mm | Standard Deviation 3.53 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 12 | -4.18 mm | Standard Deviation 4.75 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | Early termination | -0.77 mm | Standard Deviation 3.86 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | Early termination | -0.60 mm | Standard Deviation 5.36 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 6 | -2.20 mm | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 12 | -1.60 mm | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline | week 2 | -4.43 mm | Standard Deviation 9.4 |
Secondary
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | End of treatment period 2 | -9.0315 mL/m^2 | Standard Deviation 10.6354 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | End of treatment period 1 | -8.3128 mL/m^2 | Standard Deviation 9.2045 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | Early termination | 1.2208 mL/m^2 | — |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | End of treatment period 1 | -2.8341 mL/m^2 | Standard Deviation 10.6672 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | End of treatment period 2 | -7.0016 mL/m^2 | Standard Deviation 8.8423 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | End of treatment period 2 | -1.7459 mL/m^2 | Standard Deviation 6.9756 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | End of treatment period 1 | 1.5998 mL/m^2 | Standard Deviation 2.6613 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | End of treatment period 1 | -3.1748 mL/m^2 | Standard Deviation 6.3863 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | End of treatment period 2 | -4.3387 mL/m^2 | Standard Deviation 8.9773 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 6 | -6.8323 mL/m^2 | Standard Deviation 14.6055 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | Early termination | -2.3523 mL/m^2 | Standard Deviation 14.4189 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 2 | -16.6661 mL/m^2 | Standard Deviation 27.1117 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 12 | -5.5205 mL/m^2 | Standard Deviation 9.5934 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 24 | -2.2674 mL/m^2 | Standard Deviation 14.6852 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 48 | -13.5827 mL/m^2 | Standard Deviation 21.5043 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 12 | -9.9285 mL/m^2 | Standard Deviation 14.1805 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | Early termination | -6.7128 mL/m^2 | Standard Deviation 15.244 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 48 | -18.4947 mL/m^2 | Standard Deviation 12.9649 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 24 | -6.6309 mL/m^2 | Standard Deviation 19.3049 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 36 | -21.4681 mL/m^2 | Standard Deviation 6.5099 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 6 | -7.9134 mL/m^2 | Standard Deviation 10.2267 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 2 | -6.1675 mL/m^2 | Standard Deviation 12.9178 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | Week 42 | -29.9173 mL/m^2 | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | Early termination | 2.9170 mL/m^2 | Standard Deviation 6.0452 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 2 | -3.7087 mL/m^2 | Standard Deviation 2.2142 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 6 | -13.2403 mL/m^2 | Standard Deviation 18.8755 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline | week 12 | -0.9776 mL/m^2 | — |
Secondary
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | End of treatment period 1 | 0.23 cm/s | Standard Deviation 1.9 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | Early termination | -2.30 cm/s | — |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | End of treatment period 2 | 1.01 cm/s | Standard Deviation 1.75 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | End of treatment period 1 | -0.12 cm/s | Standard Deviation 0.77 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | End of treatment period 2 | 0.53 cm/s | Standard Deviation 1.57 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | End of treatment period 2 | 1.40 cm/s | Standard Deviation 1.38 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | End of treatment period 1 | 1.15 cm/s | Standard Deviation 0.66 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | End of treatment period 2 | -0.10 cm/s | Standard Deviation 1.99 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | End of treatment period 1 | 0.22 cm/s | Standard Deviation 1.62 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 12 | 0.57 cm/s | Standard Deviation 1.26 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | Early termination | 0.14 cm/s | Standard Deviation 1.43 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 6 | 0.34 cm/s | Standard Deviation 0.84 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 48 | 1.25 cm/s | Standard Deviation 1.35 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 24 | -0.55 cm/s | Standard Deviation 1.33 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 2 | -0.04 cm/s | Standard Deviation 1.62 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 6 | 0.08 cm/s | Standard Deviation 0.59 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 2 | -0.14 cm/s | Standard Deviation 0.88 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 12 | -0.03 cm/s | Standard Deviation 1.29 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 24 | 0.18 cm/s | Standard Deviation 0.65 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 36 | -0.30 cm/s | — |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 48 | 0.10 cm/s | Standard Deviation 0.46 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | Early termination | 0.67 cm/s | Standard Deviation 1.39 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 2 | -0.95 cm/s | Standard Deviation 0.78 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | Early termination | -1.20 cm/s | Standard Deviation 0.57 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline | week 6 | -0.80 cm/s | — |
Secondary
Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline
Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.
Time frame: Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination
Population: All treated participants with baseline and post baseline measurements at the specified timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | End of treatment period 2 | 0.53 cm/s | Standard Deviation 0.42 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | End of treatment period 1 | 0.56 cm/s | Standard Deviation 1.05 |
| Part A - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | Early termination | 0.40 cm/s | — |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | End of treatment period 1 | 0.03 cm/s | Standard Deviation 0.5 |
| Part A - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | End of treatment period 2 | 0.20 cm/s | Standard Deviation 0.62 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | End of treatment period 2 | 1.04 cm/s | Standard Deviation 1.57 |
| Part A - DCM-Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | End of treatment period 1 | 0.78 cm/s | Standard Deviation 0.63 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | End of treatment period 2 | -0.20 cm/s | Standard Deviation 0.94 |
| Part A - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | End of treatment period 1 | 0.06 cm/s | Standard Deviation 0.66 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 12 | 0.77 cm/s | Standard Deviation 0.83 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 6 | 0.95 cm/s | Standard Deviation 0.89 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 2 | 0.24 cm/s | Standard Deviation 0.9 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 24 | 0.17 cm/s | Standard Deviation 0.53 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 48 | 1.22 cm/s | Standard Deviation 1.27 |
| Part B - MYH7 - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | Early termination | 0.40 cm/s | Standard Deviation 1.53 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 48 | 0.07 cm/s | Standard Deviation 1.14 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | Early termination | 0.10 cm/s | Standard Deviation 0.77 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 2 | 0.06 cm/s | Standard Deviation 0.58 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 6 | 0.50 cm/s | Standard Deviation 1.39 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 12 | -0.12 cm/s | Standard Deviation 0.74 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 24 | 0.17 cm/s | Standard Deviation 0.97 |
| Part B - TTN - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 36 | -1.40 cm/s | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | Early termination | 0.67 cm/s | Standard Deviation 1 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 2 | 0.20 cm/s | Standard Deviation 1.31 |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 12 | 1.30 cm/s | — |
| Part B - DCM-Non Genetic - MYK-491 | Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline | week 6 | -0.05 cm/s | Standard Deviation 1.34 |