Cardiomyopathy, Dilated
Conditions
Keywords
Anti-beta1-receptor autoantibodies, COR-1, Heart failure
Brief summary
The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed.
Detailed description
In patients with dilated cardiomyopathy (heart is weakened and enlarged), the presence of anti-beta1-receptor autoantibodies has been shown to predict more depressed left ventricular function, increased prevalence of serious ventricular arrhythmias, sudden cardiac death, and cardiovascular mortality. In animal models, COR-1 cyclopeptide has been shown to bind to, and therefore decrease, the anti-beta1-receptor autoantibody titre. This study will investigate the safety and effectiveness of COR-1 treatment in patients with dilated cardiomyopathy. This study will be a randomized (the study treatment is assigned by chance), double-blind, (neither investigator nor patient knows the treatment that the volunteer receives), multicenter (study is conducted in more than one center) placebo-controlled (one of the treatments is inactive), parallel group study (patients in different treatment groups receive medication at the same time) in men and women who have heart failure due to dilated cardiomyopathy. Eligible patients should also have a left ventricular ejection fraction of less than or equal to 45% (measurement of the percentage of blood leaving the heart each time it contracts) and should be positive for anti-beta1-receptor autoantibodies. The study will consist of 3 phases: a screening phase, a double-blind treatment period, and a follow-up phase. Patients will be randomly assigned to 1 of 4 treatment groups: 20 mg COR-1, 80 mg COR-1, 160 mg COR-1, or placebo (inactive medication). Each patient will receive 1 intravenous dose (medication is injected into a vein) every 4 weeks for a total of 6 months. Patients will come to the study center each time they receive study medication and will remain at the center for 2 to 3 hours following the injection. Blood samples will be drawn at time points during the screening, treatment, and follow-up periods. Patients will return to the study center for follow-up visits at 3 months following completion of the 6-month treatment period. Patients will participate in the study for approximately 9 months. Patient safety will be monitored. The study drug (COR-1) is being investigated for the treatment of heart failure.
Interventions
Monthly intravenous injection for 6 months
DRUGCOR-1
Monthly intravenous injection for 6 months
DRUGStandard therapy for heart failure
All patients will continue to receive standard therapy for heart failure (ie, in accordance with guidelines) throughout the study.
Sponsors
Corimmun GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed heart failure due to dilated cardiomyopathy with left ventricular ejection fraction \< 45% * Presence of anti-beta1-receptor autoantibodies * New York Heart Association (NYHA) class II to III heart failure * Symptomatic heart failure for \>1 year and \< 8 years * Treatment with adequate doses of angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta-blockers, and optional aldosterone antagonists according to guidelines for at least six months (with the exception of lack of tolerability of any of these drugs) and at stable doses for 2 months prior to screening
Exclusion criteria
* Ischemic heart disease characterized by \>= 50% coronary artery stenosis and/or history of myocardial infarction * Third or higher degree valvular defect * Any disease requiring immunosuppressive drugs (except for \<= 5 mg/day prednisone-equivalent dose) or any clinically relevant disorder of the immune system * History of severe allergies and increased risk for anaphylactic shock (e.g., bronchial asthma) * History of, or currently active illness, considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | Baseline and Month 6 | The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (\>) 55% are considered normal. It was measured by biplane echocardiography (central assessment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | Baseline and Month 6 | The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events. |
| Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6 | Baseline and Month 6 | Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons. |
| Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Baseline and Month 6 | Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons. |
| Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | Baseline and Month 6 | A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured. |
| Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | Baseline and Month 9 | The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (\>) 55% are considered normal. It was measured by biplane echocardiography (local assessment). |
| Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Baseline and Month 6 | Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant's perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. |
| Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline and Month 6 | A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated. |
| Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline and Month 6 | A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated. |
| Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Baseline and Month 6 | Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances \[20-100 m\]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. | 10 |
| COR-1 20 Milligram (mg) COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. | 8 |
| COR-1 80 mg COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. | 6 |
| COR-1 160 mg COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. | 12 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 | 2 |
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | COR-1 20 Milligram (mg) | COR-1 80 mg | COR-1 160 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 9.61 | 57.5 years STANDARD_DEVIATION 10.92 | 62 years STANDARD_DEVIATION 13.59 | 59.8 years STANDARD_DEVIATION 11.88 | 59.6 years STANDARD_DEVIATION 10.97 |
| Region of Enrollment Germany | 10 participants | 8 participants | 6 participants | 12 participants | 36 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 5 Participants | 10 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 10 | 7 / 8 | 5 / 6 | 6 / 12 |
| serious Total, serious adverse events | 1 / 10 | 1 / 8 | 1 / 6 | 6 / 12 |
Outcome results
Primary
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6
The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (\>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).
Time frame: Baseline and Month 6
Population: Intention-to-treat (ITT) population included all participants who were randomly assigned to treatment. Missing data was imputed using last observation carried forward (LOCF) method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | Baseline | 35.4 Percentage of blood pumped out | Standard Deviation 11.72 |
| Placebo | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | Change at Month 6 | -1.6 Percentage of blood pumped out | Standard Deviation 5.94 |
| COR-1 20 Milligram (mg) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | Change at Month 6 | 0.8 Percentage of blood pumped out | Standard Deviation 5.55 |
| COR-1 20 Milligram (mg) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | Baseline | 29.4 Percentage of blood pumped out | Standard Deviation 12.06 |
| COR-1 80 mg | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | Baseline | 35.0 Percentage of blood pumped out | Standard Deviation 13.42 |
| COR-1 80 mg | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | Change at Month 6 | 5.4 Percentage of blood pumped out | Standard Deviation 10.11 |
| COR-1 160 mg | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | Baseline | 32.4 Percentage of blood pumped out | Standard Deviation 10.77 |
| COR-1 160 mg | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | Change at Month 6 | -0.9 Percentage of blood pumped out | Standard Deviation 3.09 |
Secondary
Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6
Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons.
Time frame: Baseline and Month 6
Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Baseline | 5.6 Centimeter (cm)/ Second (sec) | Standard Deviation 1.52 |
| Placebo | Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Change at Month 6 | -0.2 Centimeter (cm)/ Second (sec) | Standard Deviation 0.45 |
| COR-1 20 Milligram (mg) | Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Change at Month 6 | 0.0 Centimeter (cm)/ Second (sec) | Standard Deviation 0 |
| COR-1 20 Milligram (mg) | Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Baseline | 5.2 Centimeter (cm)/ Second (sec) | Standard Deviation 1.1 |
| COR-1 80 mg | Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Baseline | 4.0 Centimeter (cm)/ Second (sec) | — |
| COR-1 80 mg | Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Change at Month 6 | 0.0 Centimeter (cm)/ Second (sec) | — |
| COR-1 160 mg | Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Baseline | 5.8 Centimeter (cm)/ Second (sec) | Standard Deviation 1.71 |
| COR-1 160 mg | Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Change at Month 6 | 0.0 Centimeter (cm)/ Second (sec) | Standard Deviation 0 |
Secondary
Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6
Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons.
Time frame: Baseline and Month 6
Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. No participants were evaluable for arms COR-1 80 mg and COR-1 160 mg.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6 | Baseline | 45.0 Centimeter (cm) | Standard Deviation 31.11 |
| Placebo | Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6 | Change at Month 6 | 0.0 Centimeter (cm) | Standard Deviation 0 |
| COR-1 20 Milligram (mg) | Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6 | Baseline | 21.0 Centimeter (cm) | — |
| COR-1 20 Milligram (mg) | Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6 | Change at Month 6 | 0.0 Centimeter (cm) | — |
Secondary
Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6
A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured.
Time frame: Baseline and Month 6
Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | Baseline | 421.1 Meter | Standard Deviation 113.29 |
| Placebo | Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | Change at Month 6 | 38.7 Meter | Standard Deviation 63.11 |
| COR-1 20 Milligram (mg) | Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | Change at Month 6 | -8.7 Meter | Standard Deviation 104.35 |
| COR-1 20 Milligram (mg) | Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | Baseline | 451.1 Meter | Standard Deviation 51.02 |
| COR-1 80 mg | Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | Baseline | 395.2 Meter | Standard Deviation 81.03 |
| COR-1 80 mg | Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | Change at Month 6 | 12.8 Meter | Standard Deviation 57.7 |
| COR-1 160 mg | Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | Baseline | 420.7 Meter | Standard Deviation 109.77 |
| COR-1 160 mg | Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | Change at Month 6 | 2.4 Meter | Standard Deviation 41.01 |
Secondary
Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated.
Time frame: Baseline and Month 6
Population: Safety population included all participants who received at least 1 dose of the study agent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Mean Heart Rate | 74.6 Beats per minute | Standard Deviation 7 |
| Placebo | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Mean Heart Rate | 1.3 Beats per minute | Standard Deviation 6.68 |
| Placebo | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Maximum Heart Rate | 126.4 Beats per minute | Standard Deviation 18.28 |
| Placebo | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Maximum Heart Rate | -0.8 Beats per minute | Standard Deviation 15.24 |
| Placebo | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Minimum Heart Rate | 51.6 Beats per minute | Standard Deviation 11.54 |
| Placebo | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Minimum Heart Rate | 0.5 Beats per minute | Standard Deviation 3.39 |
| COR-1 20 Milligram (mg) | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Minimum Heart Rate | 0.1 Beats per minute | Standard Deviation 3.93 |
| COR-1 20 Milligram (mg) | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Maximum Heart Rate | 5.4 Beats per minute | Standard Deviation 40.15 |
| COR-1 20 Milligram (mg) | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Mean Heart Rate | 76.9 Beats per minute | Standard Deviation 10.92 |
| COR-1 20 Milligram (mg) | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Maximum Heart Rate | 130.3 Beats per minute | Standard Deviation 33.26 |
| COR-1 20 Milligram (mg) | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Mean Heart Rate | -0.9 Beats per minute | Standard Deviation 3.63 |
| COR-1 20 Milligram (mg) | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Minimum Heart Rate | 59.3 Beats per minute | Standard Deviation 13.12 |
| COR-1 80 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Mean Heart Rate | -5.8 Beats per minute | Standard Deviation 10.18 |
| COR-1 80 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Maximum Heart Rate | 123.0 Beats per minute | Standard Deviation 15.26 |
| COR-1 80 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Maximum Heart Rate | 0.0 Beats per minute | Standard Deviation 25.3 |
| COR-1 80 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Minimum Heart Rate | -7.8 Beats per minute | Standard Deviation 4.5 |
| COR-1 80 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Minimum Heart Rate | 66.0 Beats per minute | Standard Deviation 4.16 |
| COR-1 80 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Mean Heart Rate | 84.2 Beats per minute | Standard Deviation 11.43 |
| COR-1 160 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Minimum Heart Rate | 58.7 Beats per minute | Standard Deviation 6.65 |
| COR-1 160 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Minimum Heart Rate | -2.3 Beats per minute | Standard Deviation 10.09 |
| COR-1 160 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Mean Heart Rate | 1.4 Beats per minute | Standard Deviation 6.97 |
| COR-1 160 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Change at Month 6: Maximum Heart Rate | -2.0 Beats per minute | Standard Deviation 31.56 |
| COR-1 160 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Mean Heart Rate | 75.3 Beats per minute | Standard Deviation 8.59 |
| COR-1 160 mg | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | Baseline: Maximum Heart Rate | 125.1 Beats per minute | Standard Deviation 35.23 |
Secondary
Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9
The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (\>) 55% are considered normal. It was measured by biplane echocardiography (local assessment).
Time frame: Baseline and Month 9
Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | Baseline | 32.6 Percentage of blood pumped out | Standard Deviation 5.78 |
| Placebo | Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | Change at Month 9 | -0.8 Percentage of blood pumped out | Standard Deviation 4.39 |
| COR-1 20 Milligram (mg) | Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | Change at Month 9 | -1.9 Percentage of blood pumped out | Standard Deviation 5.99 |
| COR-1 20 Milligram (mg) | Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | Baseline | 33.6 Percentage of blood pumped out | Standard Deviation 9.77 |
| COR-1 80 mg | Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | Baseline | 35.3 Percentage of blood pumped out | Standard Deviation 8.57 |
| COR-1 80 mg | Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | Change at Month 9 | 3.8 Percentage of blood pumped out | Standard Deviation 4.02 |
| COR-1 160 mg | Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | Baseline | 32.5 Percentage of blood pumped out | Standard Deviation 9.27 |
| COR-1 160 mg | Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | Change at Month 9 | -1.8 Percentage of blood pumped out | Standard Deviation 3.13 |
Secondary
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6
Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant's perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL.
Time frame: Baseline and Month 6
Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Baseline | 23.7 Units on a scale | Standard Deviation 11.57 |
| Placebo | Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Change at Month 6 | 3.3 Units on a scale | Standard Deviation 10.7 |
| COR-1 20 Milligram (mg) | Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Change at Month 6 | 3.3 Units on a scale | Standard Deviation 16.25 |
| COR-1 20 Milligram (mg) | Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Baseline | 21.4 Units on a scale | Standard Deviation 12.09 |
| COR-1 80 mg | Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Baseline | 33.2 Units on a scale | Standard Deviation 23.09 |
| COR-1 80 mg | Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Change at Month 6 | 1.8 Units on a scale | Standard Deviation 9.5 |
| COR-1 160 mg | Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Baseline | 25.9 Units on a scale | Standard Deviation 25.27 |
| COR-1 160 mg | Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Change at Month 6 | 2.4 Units on a scale | Standard Deviation 20.5 |
Secondary
Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6
The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events.
Time frame: Baseline and Month 6
Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | Baseline | 5678.0 Picogram (pg)/ Milliliter (mL) | Standard Deviation 9347.1 |
| Placebo | Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | Change at Month 6 | -805.7 Picogram (pg)/ Milliliter (mL) | Standard Deviation 1241 |
| COR-1 20 Milligram (mg) | Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | Change at Month 6 | 1363.4 Picogram (pg)/ Milliliter (mL) | Standard Deviation 3948.7 |
| COR-1 20 Milligram (mg) | Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | Baseline | 2215.9 Picogram (pg)/ Milliliter (mL) | Standard Deviation 1692.1 |
| COR-1 80 mg | Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | Baseline | 971.4 Picogram (pg)/ Milliliter (mL) | Standard Deviation 665.1 |
| COR-1 80 mg | Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | Change at Month 6 | 392.8 Picogram (pg)/ Milliliter (mL) | Standard Deviation 295.7 |
| COR-1 160 mg | Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | Baseline | 2299.4 Picogram (pg)/ Milliliter (mL) | Standard Deviation 2024.1 |
| COR-1 160 mg | Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | Change at Month 6 | 1109.6 Picogram (pg)/ Milliliter (mL) | Standard Deviation 2130.6 |
Secondary
Number of Participants With Holter Electrocardiography (ECG) Parameters
A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated.
Time frame: Baseline and Month 6
Population: Safety population included all participants who received at least 1 dose of the study agent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Abnormal, CS | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Abnormal, NCS | 5 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 1001-2400/24h | 4 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Abnormal, NCS | 6 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Normal | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: II, IIIa, IVa, IVb | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: 0 No VES | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IVb Runs, repetitive VES | 1 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: V Early occurring VES(R-on T phenomenon) | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IVb Runs, repetitive VES | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: I Occasional individual VES (< 30/h) | 3 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IVa Couplets, repetitive VES | 1 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IVa Couplets, repetitive VES | 1 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IIIb Ventricular bigeminy | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: II Frequent VES (>30/h) | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Sinus rhythm | 5 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IIIa Polymorphous VES | 1 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block I | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IIIa Polymorphous VES | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: II Frequent VES (>30/h) | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Atrial fibrillation | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: No block | 7 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: I Occasional individual VES (< 30/h) | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: 0 No VES | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline:Atrial fibrillation-paroxysmal/persistent | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Normal | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 1001-2400/24h | 4 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 241-1000/24h | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Other | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: II, IIIa, IVa, IVb | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 0-240/24h | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 1001-2400/24h | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline; AV junctional, 0-240/24h | 5 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block II | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 241-1000/24h | 1 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 0-240/24h | 5 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV junctional, 241-1000/24h | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Abnormal, CS | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Other | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Atrial fibrillation-paroxysmal/persistent | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV junctional, 1001-2400/24h | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: V Early occurring VES (R-on T phenomenon) | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Atrial fibrillation | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Sinus rhythm | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block III | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 0-240/24h | 1 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block III | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block II | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block I | 0 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 241-1000/24h | 2 Participants |
| Placebo | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: No block | 6 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 241-1000/24h | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: No block | 7 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block I | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block II | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block III | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Sinus rhythm | 4 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Atrial fibrillation | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline:Atrial fibrillation-paroxysmal/persistent | 1 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Other | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline; AV junctional, 0-240/24h | 6 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV junctional, 241-1000/24h | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV junctional, 1001-2400/24h | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 0-240/24h | 1 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 1001-2400/24h | 3 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: 0 No VES | 1 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: I Occasional individual VES (< 30/h) | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: II Frequent VES (>30/h) | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IIIa Polymorphous VES | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IIIb Ventricular bigeminy | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IVa Couplets, repetitive VES | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IVb Runs, repetitive VES | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: V Early occurring VES(R-on T phenomenon) | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: II, IIIa, IVa, IVb | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Normal | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Abnormal, NCS | 5 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Abnormal, CS | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: No block | 7 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block I | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block II | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block III | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Sinus rhythm | 4 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Atrial fibrillation | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Atrial fibrillation-paroxysmal/persistent | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Other | 1 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 0-240/24h | 5 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 241-1000/24h | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 1001-2400/24h | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 0-240/24h | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 241-1000/24h | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 1001-2400/24h | 3 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: 0 No VES | 1 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: I Occasional individual VES (< 30/h) | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: II Frequent VES (>30/h) | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IIIa Polymorphous VES | 3 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IVa Couplets, repetitive VES | 1 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IVb Runs, repetitive VES | 1 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: V Early occurring VES (R-on T phenomenon) | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: II, IIIa, IVa, IVb | 1 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Normal | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Abnormal, NCS | 6 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Abnormal, CS | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Atrial fibrillation | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Abnormal, CS | 2 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: No block | 5 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block III | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block I | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 0-240/24h | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Abnormal, NCS | 3 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block II | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IVb Runs, repetitive VES | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block III | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Sinus rhythm | 3 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV junctional, 1001-2400/24h | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block II | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IVa Couplets, repetitive VES | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Atrial fibrillation-paroxysmal/persistent | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV junctional, 241-1000/24h | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: V Early occurring VES (R-on T phenomenon) | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Other | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 0-240/24h | 4 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline; AV junctional, 0-240/24h | 4 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 241-1000/24h | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: No block | 5 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 1001-2400/24h | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Other | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: II, IIIa, IVa, IVb | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 0-240/24h | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 241-1000/24h | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline:Atrial fibrillation-paroxysmal/persistent | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block I | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 1001-2400/24h | 3 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: 0 No VES | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Atrial fibrillation | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Normal | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: I Occasional individual VES (< 30/h) | 2 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: II Frequent VES (>30/h) | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: II Frequent VES (>30/h) | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IIIa Polymorphous VES | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IIIb Ventricular bigeminy | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: I Occasional individual VES (< 30/h) | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Sinus rhythm | 4 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IVa Couplets, repetitive VES | 2 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IVb Runs, repetitive VES | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: 0 No VES | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IIIa Polymorphous VES | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: V Early occurring VES(R-on T phenomenon) | 0 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: II, IIIa, IVa, IVb | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 1001-2400/24h | 2 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Normal | 2 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Abnormal, CS | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Abnormal, NCS | 1 Participants |
| COR-1 80 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 241-1000/24h | 2 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: II, IIIa, IVa, IVb | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 1001-2400/24h | 5 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Abnormal, CS | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block II | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IVa Couplets, repetitive VES | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 241-1000/24h | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: No block | 5 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 0-240/24h | 4 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IIIa Polymorphous VES | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Normal | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block I | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IVa Couplets, repetitive VES | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 1001-2400/24h | 4 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Atrial fibrillation | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block II | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV junctional, 1001-2400/24h | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Abnormal, CS | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV block III | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: 0 No VES | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: IVb Runs, repetitive VES | 2 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: 0 No VES | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Sinus rhythm | 6 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: No block | 7 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: II, IIIa, IVa, IVb | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IVb Runs, repetitive VES | 3 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Atrial fibrillation | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV junctional, 241-1000/24h | 3 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Abnormal, NCS | 5 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: I Occasional individual VES (< 30/h) | 2 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Atrial fibrillation-paroxysmal/persistent | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Sinus rhythm | 7 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Normal | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: II Frequent VES (>30/h) | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Other | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline; AV junctional, 0-240/24h | 6 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: V Early occurring VES (R-on T phenomenon) | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Ventricular, 241-1000/24h | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 0-240/24h | 4 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block III | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: AV block I | 3 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Abnormal, NCS | 8 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 241-1000/24h | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: Other | 2 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IIIa Polymorphous VES | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: I Occasional individual VES (< 30/h) | 4 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: AV junctional, 1001-2400/24h | 2 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: II Frequent VES (>30/h) | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: V Early occurring VES(R-on T phenomenon) | 0 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline: IIIb Ventricular bigeminy | 1 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Month 6: Ventricular, 0-240/24h | 2 Participants |
| COR-1 160 mg | Number of Participants With Holter Electrocardiography (ECG) Parameters | Baseline:Atrial fibrillation-paroxysmal/persistent | 1 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression
Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances \[20-100 m\]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants).
Time frame: Baseline and Month 6
Population: ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage II (n= 7, 7, 5, 8) | 3 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Baseline: Stage III (n= 10, 8, 6, 12) | 3 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage III (n= 7, 7, 5, 8) | 3 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage I (n= 7, 7, 5, 8) | 1 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Baseline: Stage II (n= 10, 8, 6, 12) | 7 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage I (n= 7, 7, 5, 8) | 1 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage II (n= 7, 7, 5, 8) | 4 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage III (n= 7, 7, 5, 8) | 2 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Baseline: Stage III (n= 10, 8, 6, 12) | 0 Participants |
| COR-1 20 Milligram (mg) | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Baseline: Stage II (n= 10, 8, 6, 12) | 8 Participants |
| COR-1 80 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage I (n= 7, 7, 5, 8) | 0 Participants |
| COR-1 80 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Baseline: Stage II (n= 10, 8, 6, 12) | 3 Participants |
| COR-1 80 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Baseline: Stage III (n= 10, 8, 6, 12) | 3 Participants |
| COR-1 80 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage II (n= 7, 7, 5, 8) | 3 Participants |
| COR-1 80 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage III (n= 7, 7, 5, 8) | 2 Participants |
| COR-1 160 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage II (n= 7, 7, 5, 8) | 6 Participants |
| COR-1 160 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Baseline: Stage III (n= 10, 8, 6, 12) | 5 Participants |
| COR-1 160 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Baseline: Stage II (n= 10, 8, 6, 12) | 7 Participants |
| COR-1 160 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage I (n= 7, 7, 5, 8) | 0 Participants |
| COR-1 160 mg | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Month 6: Stage III (n= 7, 7, 5, 8) | 2 Participants |