Ischemic Heart Disease
Conditions
Keywords
VM202, Engensis, Coronary Artery Bypass Graft
Brief summary
The purpose of this study is to evaluate the safety of VM202 (Engensis) direct injection into the cardiac muscles of the coronary artery territory where complete revascularization could not be done even through Coronary Artery Bypass Graft (CABG).
Detailed description
All the patients expected to undergo Coronary Artery Bypass Graft (CABG) will screen for the participation in the clinical study. Subjects who signed the informed consent will receive all the screening tests within 21 days before surgery (Day 0). VM202 (Engensis) will be injected into 4 sites or 8 sites on the coronary artery where complete revascularization was not done since vascular anastomosis could not be performed due to the bad vascular condition during surgery. VM202 (Engensis) will be administered to Group1 (0.5 mg), Group 2 (1 mg) and Group 3 (2 mg) at different concentrations. Subjects will be scheduled to get inpatient treatment during the gene therapy period (7 days) and follow-up tests at Week 2, 4, 8, 12 and 24 based on surgery day (Day 0). Adverse events and concomitant drugs will be checked. Safety: Evaluated for 6 months after the administration of VM202 (Engensis). 1. Dose-Limiting Toxicity (DLT) 2. Tolerated Dose (TD) 3. Adverse events, vital signs, physical examination and laboratory test values 4. Major Adverse Cardiac Event (MACE) - cardiac death, myocardial infarction, ventricular arrhythmia requiring treatment, or hospitalization for revascularization of target blood vessels) 5. Safety of VM202 intramyocardial injection: persistent hemorrhage, arrhythmia and other complications Secondary endpoints \- Efficacy 1. Changes in cardiac function: Left ventricular ejection fraction and cardiac function in the local region by cardiac MRI (Magnetic Resonance Imaging), myocardial SPECT (99 mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography) and Trans Thoracic echocardiography (TTE) 2. Size of viable myocardium: By cardiac MRI (myocardial thickness of intramyocardial gene injection site, gadolinium late contrast enhancement range and the exercise intensity of the local region) 3. Changes in myocardial ischemic area: By myocardial SPECT (blood flow changes at intramyocardial gene injection site from resting to stress condition)
Interventions
BIOLOGICALVM202-0.5 mg
0.5 mg intramyocardial injection
BIOLOGICALVM202-1.0 mg
1 mg intramyocardial injection
BIOLOGICALVM202-2.0 mg
2 mg intramyocardial injection
Sponsors
Helixmith Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose-escalation
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥ 19 and ≤ 75 years 2. Patients in whom decrease of myocardial perfusion in coronary artery territories (rest perfusion - stress perfusion: ≥ 7%) was observed by myocardial SPECT 3. Patients judged to have possibly incomplete revascularization based on the observation of the coronary artery's internal diameter of ≤ 1 mm, diffuse atherosclerosis or severe calcification on coronary angiography, or patients judged to have some myocardial perfusion territories that could not be performed Coronary Artery Bypass Graft 4. Patients who or whose legal representative can write the informed consent before the initiation of the clinical study and comply with the requirements
Exclusion criteria
1. Patients with progressive or present heart failure 2. Patients with uncontrolled ventricular arrhythmia on electrocardiogram, or who have been treated for ventricular arrhythmia 3. Patients with current or history of malignant tumor 4. Patients with severe infectious disease 5. Patients with uncontrolled hematologic disorders 6. Patients requiring surgery for the accompanying valve diseases or left ventricular volume reduction surgery 7. Patients with current or history of proliferative retinopathy 8. Patients with remaining life of less than 1 year and severe accompanying diseases enough to die during the clinical follow-up period 9. Patients with history of drug or alcohol abuse within the recent 3 months 10. Women who are pregnant or breast feeding or postmenopausal women of childbearing age. However, women who underwent surgical sterilization including hysterectomy or bilateral tubal ligation can participate in this clinical trial. Even though they consent to the contraception, they cannot be enrolled. 11. Patients in inappropriate condition judged by investigators 12. Patients with cerebrovascular diseases (cerebral infarction, cerebral bleeding or transient ischemic attack that are currently occurring or occurred within 6 months) 13. Patients with idiopathic hypertension who are not controlled with drugs 14. Patients with severe hepatic disorders 15. Patients with severe renal disorders 16. Patients who underwent Coronary Artery Bypass Graft 17. Patients who underwent angioplasty within 1 year before their enrollment in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Adverse Events - Total Adverse Events (AE) | 24 weeks | Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results |
| The Severity of Adverse Events - Total Adverse Events by Severity | 24 weeks | Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Size of Viable Myocardium - End-Systolic Thickness | Day 0, 12 weeks, 24 weeks | The size of the viable myocardium was evaluated based on the myocardium thickness at the site of intramyocardial gene injection by Magnetic Resonance Imaging - End-Systolic Thickness. Using cardiac MRI, the myocardial thickness at the gene injection site, the extent of late gadolinium enhancement, and local wall motion strength will be evaluated. Differences between groups before and after VM202RY administration will be tested using the Kruskal-Wallis test. |
| Changes in Size of Viable Myocardium - End-Diastolic Thickness | Day 0, 12 weeks, 24 weeks | The size of the viable myocardium was evaluated based on the myocardium thickness at the site of intramyocardial gene injection by Magnetic Resonance Imaging - End-Diastolic Thickness. Using cardiac MRI, the myocardial thickness at the gene injection site, the extent of late gadolinium enhancement, and local wall motion strength will be evaluated. Differences between groups before and after VM202RY administration will be tested using the Kruskal-Wallis test. |
| Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging | Day 0, 12 weeks, 24 weeks | Changes in Percentage of Left Ventricular Ejection Fraction by Cardiac Magnetic Resonance Imaging (MRI). Cardiac MRI will be used to monitor for the development of intramyocardial hemangiomas. Analysis will follow the standard cardiac MRI protocols of the Department of Radiology at Seoul National University Hospital, using an appropriate segment model based on the patient's heart size. Parameters evaluated will include left ventricular volume (mL), wall motion index, myocardial thickness (mm), and LVEF (%). Comparisons will be made between baseline/screening and follow-up measurements for each patient, as well as between treatment groups. |
| Changes in Myocardial Ischemic Area - Resting Condition | Day 0, 12 weeks, 24 weeks | Changes in Myocardial Ischemic Area evaluated by 99mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography (SPECT) based on Percentage of perfusion volume - Resting Condition |
| Changes in Myocardial Ischemic Area - Stress Condition | Day 0, 12 weeks, 24 weeks | Changes in Myocardial Ischemic Area evaluated by 99mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography (SPECT) based on Percentage of perfusion volume - Stress Condition |
| Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Day 0, Day 7, 12 weeks, 24 weeks | Changes from screening in cardiac function evaluated based on Percentage of Left Ventricular Ejection Fraction by cardiac Trans-thoracic Echocardiography (TTE). From transthoracic echocardiography, left ventricular diameter (mm), ejection fraction (%), and wall thickness (mL) will be measured and compared from Screening/Baseline to follow-up results after surgery. The Wall Motion Score Index will be calculated by dividing the myocardium into 16 segments and assigning a score to each area based on motion: \[1 = normal, 2 = hypokinetic, 3 = akinetic, 4 = dyskinetic\]. The total score for the entire myocardium and the right coronary artery region will be averaged by the number of segments. |
Countries
South Korea
Participant flow
Recruitment details
16 participants were screened. 9 participants were randomized/enrolled, with 7 screen failures.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - VM202 - 0.5 mg/ 1mL VM202RY 0.5 mg/ 1 mL was intramyocardially injected into 4 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft. | 3 |
| Group 2 - VM202 - 1.0 mg/2 mL VM202RY 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft. | 3 |
| Group 3 - VM202 - 2 mg/4 mL VM202RY 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft. | 3 |
| Total | 9 |
Baseline characteristics
| Characteristic | Group 1 - VM202 - 0.5 mg/ 1mL | Group 2 - VM202 - 1.0 mg/2 mL | Group 3 - VM202 - 2 mg/4 mL | Total |
|---|---|---|---|---|
| Age, Continuous | 61.00 years STANDARD_DEVIATION 12.77 | 59.00 years STANDARD_DEVIATION 6.93 | 67.67 years STANDARD_DEVIATION 6.11 | 62.56 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment South Korea | 3 participants | 3 participants | 3 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 3 / 3 |
| serious Total, serious adverse events | 1 / 3 | 0 / 3 | 0 / 3 |
Outcome results
Primary
The Incidence of Adverse Events - Total Adverse Events (AE)
Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results
Time frame: 24 weeks
Population: Total Number of Adverse Events (ITT Safety)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - 0.5 mg/1 mL | The Incidence of Adverse Events - Total Adverse Events (AE) | AEs related to Investigational Product | 0 Total AEs |
| Group 1 - 0.5 mg/1 mL | The Incidence of Adverse Events - Total Adverse Events (AE) | Treatment Emergent AEs | 58 Total AEs |
| Group 1 - 0.5 mg/1 mL | The Incidence of Adverse Events - Total Adverse Events (AE) | Serious Adverse Events | 2 Total AEs |
| Group 2 - 1.0 mg/2 mL | The Incidence of Adverse Events - Total Adverse Events (AE) | AEs related to Investigational Product | 0 Total AEs |
| Group 2 - 1.0 mg/2 mL | The Incidence of Adverse Events - Total Adverse Events (AE) | Treatment Emergent AEs | 18 Total AEs |
| Group 2 - 1.0 mg/2 mL | The Incidence of Adverse Events - Total Adverse Events (AE) | Serious Adverse Events | 0 Total AEs |
| Group 3 - 2 mg/4 mL | The Incidence of Adverse Events - Total Adverse Events (AE) | Treatment Emergent AEs | 36 Total AEs |
| Group 3 - 2 mg/4 mL | The Incidence of Adverse Events - Total Adverse Events (AE) | Serious Adverse Events | 0 Total AEs |
| Group 3 - 2 mg/4 mL | The Incidence of Adverse Events - Total Adverse Events (AE) | AEs related to Investigational Product | 0 Total AEs |
Primary
The Severity of Adverse Events - Total Adverse Events by Severity
Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results
Time frame: 24 weeks
Population: Total Adverse Events by Severity (ITT Safety)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - 0.5 mg/1 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 3/Severe-Severity of AEs | 0 Total AEs |
| Group 1 - 0.5 mg/1 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 1/Mild-Severity of AEs | 31 Total AEs |
| Group 1 - 0.5 mg/1 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 4/Severe-Severity of AEs | 0 Total AEs |
| Group 1 - 0.5 mg/1 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 2/Moderate-Severity of AEs | 27 Total AEs |
| Group 2 - 1.0 mg/2 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 3/Severe-Severity of AEs | 0 Total AEs |
| Group 2 - 1.0 mg/2 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 2/Moderate-Severity of AEs | 12 Total AEs |
| Group 2 - 1.0 mg/2 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 1/Mild-Severity of AEs | 6 Total AEs |
| Group 2 - 1.0 mg/2 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 4/Severe-Severity of AEs | 0 Total AEs |
| Group 3 - 2 mg/4 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 4/Severe-Severity of AEs | 0 Total AEs |
| Group 3 - 2 mg/4 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 1/Mild-Severity of AEs | 12 Total AEs |
| Group 3 - 2 mg/4 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 2/Moderate-Severity of AEs | 24 Total AEs |
| Group 3 - 2 mg/4 mL | The Severity of Adverse Events - Total Adverse Events by Severity | Grade 3/Severe-Severity of AEs | 0 Total AEs |
Secondary
Changes in Myocardial Ischemic Area - Resting Condition
Changes in Myocardial Ischemic Area evaluated by 99mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography (SPECT) based on Percentage of perfusion volume - Resting Condition
Time frame: Day 0, 12 weeks, 24 weeks
Population: Intent to Treat - Changes in Myocardial Ischemic Area evaluated by SPECT based on Percentage of perfusion volume - Resting Condition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - 0.5 mg/1 mL | Changes in Myocardial Ischemic Area - Resting Condition | Week 12 | 7.33 percentage of Perfusion Volume | Standard Deviation 8.5 |
| Group 1 - 0.5 mg/1 mL | Changes in Myocardial Ischemic Area - Resting Condition | Week 24 | -3.50 percentage of Perfusion Volume | Standard Deviation 0.71 |
| Group 2 - 1.0 mg/2 mL | Changes in Myocardial Ischemic Area - Resting Condition | Week 12 | 0.83 percentage of Perfusion Volume | Standard Deviation 1.53 |
| Group 2 - 1.0 mg/2 mL | Changes in Myocardial Ischemic Area - Resting Condition | Week 24 | 1.33 percentage of Perfusion Volume | Standard Deviation 2.75 |
| Group 3 - 2 mg/4 mL | Changes in Myocardial Ischemic Area - Resting Condition | Week 12 | 4.67 percentage of Perfusion Volume | Standard Deviation 4.86 |
| Group 3 - 2 mg/4 mL | Changes in Myocardial Ischemic Area - Resting Condition | Week 24 | 5.17 percentage of Perfusion Volume | Standard Deviation 10.41 |
Secondary
Changes in Myocardial Ischemic Area - Stress Condition
Changes in Myocardial Ischemic Area evaluated by 99mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography (SPECT) based on Percentage of perfusion volume - Stress Condition
Time frame: Day 0, 12 weeks, 24 weeks
Population: Intent to Treat - Changes in Myocardial Ischemic Area evaluated by SPECT based on Percentage of perfusion volume - Stress Condition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - 0.5 mg/1 mL | Changes in Myocardial Ischemic Area - Stress Condition | Week 24 | 7.50 percentage of Perfusion Volume | Standard Deviation 7.07 |
| Group 1 - 0.5 mg/1 mL | Changes in Myocardial Ischemic Area - Stress Condition | Week 12 | 7.83 percentage of Perfusion Volume | Standard Deviation 7.91 |
| Group 2 - 1.0 mg/2 mL | Changes in Myocardial Ischemic Area - Stress Condition | Week 12 | 8.33 percentage of Perfusion Volume | Standard Deviation 1.53 |
| Group 2 - 1.0 mg/2 mL | Changes in Myocardial Ischemic Area - Stress Condition | Week 24 | 5.00 percentage of Perfusion Volume | Standard Deviation 1.5 |
| Group 3 - 2 mg/4 mL | Changes in Myocardial Ischemic Area - Stress Condition | Week 12 | 1.67 percentage of Perfusion Volume | Standard Deviation 7.75 |
| Group 3 - 2 mg/4 mL | Changes in Myocardial Ischemic Area - Stress Condition | Week 24 | 5.33 percentage of Perfusion Volume | Standard Deviation 8.13 |
Secondary
Changes in Size of Viable Myocardium - End-Diastolic Thickness
The size of the viable myocardium was evaluated based on the myocardium thickness at the site of intramyocardial gene injection by Magnetic Resonance Imaging - End-Diastolic Thickness. Using cardiac MRI, the myocardial thickness at the gene injection site, the extent of late gadolinium enhancement, and local wall motion strength will be evaluated. Differences between groups before and after VM202RY administration will be tested using the Kruskal-Wallis test.
Time frame: Day 0, 12 weeks, 24 weeks
Population: Intent to Treat - myocardium thickness by Magnetic Resonance Imaging - End-Diastolic Thickness
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - 0.5 mg/1 mL | Changes in Size of Viable Myocardium - End-Diastolic Thickness | Week 12 | 0.47 mm | Standard Deviation 1.13 |
| Group 1 - 0.5 mg/1 mL | Changes in Size of Viable Myocardium - End-Diastolic Thickness | Week 24 | 1.85 mm | Standard Deviation 0.1 |
| Group 2 - 1.0 mg/2 mL | Changes in Size of Viable Myocardium - End-Diastolic Thickness | Week 12 | 0.71 mm | Standard Deviation 0.23 |
| Group 2 - 1.0 mg/2 mL | Changes in Size of Viable Myocardium - End-Diastolic Thickness | Week 24 | 0.43 mm | Standard Deviation 1.53 |
| Group 3 - 2 mg/4 mL | Changes in Size of Viable Myocardium - End-Diastolic Thickness | Week 12 | 0.44 mm | Standard Deviation 0.46 |
| Group 3 - 2 mg/4 mL | Changes in Size of Viable Myocardium - End-Diastolic Thickness | Week 24 | 0.17 mm | Standard Deviation 0.81 |
Secondary
Changes in Size of Viable Myocardium - End-Systolic Thickness
The size of the viable myocardium was evaluated based on the myocardium thickness at the site of intramyocardial gene injection by Magnetic Resonance Imaging - End-Systolic Thickness. Using cardiac MRI, the myocardial thickness at the gene injection site, the extent of late gadolinium enhancement, and local wall motion strength will be evaluated. Differences between groups before and after VM202RY administration will be tested using the Kruskal-Wallis test.
Time frame: Day 0, 12 weeks, 24 weeks
Population: Intent to Treat - myocardium thickness by Magnetic Resonance Imaging - End-Systolic Thickness
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - 0.5 mg/1 mL | Changes in Size of Viable Myocardium - End-Systolic Thickness | Week 12 | 0.58 mm | Standard Deviation 1.4 |
| Group 1 - 0.5 mg/1 mL | Changes in Size of Viable Myocardium - End-Systolic Thickness | Week 24 | 0.99 mm | Standard Deviation 2.59 |
| Group 2 - 1.0 mg/2 mL | Changes in Size of Viable Myocardium - End-Systolic Thickness | Week 12 | 0.08 mm | Standard Deviation 1.67 |
| Group 2 - 1.0 mg/2 mL | Changes in Size of Viable Myocardium - End-Systolic Thickness | Week 24 | 0.36 mm | Standard Deviation 1.63 |
| Group 3 - 2 mg/4 mL | Changes in Size of Viable Myocardium - End-Systolic Thickness | Week 12 | 0.93 mm | Standard Deviation 1.37 |
| Group 3 - 2 mg/4 mL | Changes in Size of Viable Myocardium - End-Systolic Thickness | Week 24 | 1.15 mm | Standard Deviation 1.38 |
Secondary
Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography
Changes from screening in cardiac function evaluated based on Percentage of Left Ventricular Ejection Fraction by cardiac Trans-thoracic Echocardiography (TTE). From transthoracic echocardiography, left ventricular diameter (mm), ejection fraction (%), and wall thickness (mL) will be measured and compared from Screening/Baseline to follow-up results after surgery. The Wall Motion Score Index will be calculated by dividing the myocardium into 16 segments and assigning a score to each area based on motion: \[1 = normal, 2 = hypokinetic, 3 = akinetic, 4 = dyskinetic\]. The total score for the entire myocardium and the right coronary artery region will be averaged by the number of segments.
Time frame: Day 0, Day 7, 12 weeks, 24 weeks
Population: Intent to Treat - Left Ventricular Ejection Percentage Fraction - Measured by Trans Thoracic Echocardiography
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - 0.5 mg/1 mL | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Week 12 | 3.0 percentage of change from screening | Standard Deviation 6.08 |
| Group 1 - 0.5 mg/1 mL | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Day 7 | -1.00 percentage of change from screening | Standard Deviation 2.65 |
| Group 1 - 0.5 mg/1 mL | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Week 24 | 8.0 percentage of change from screening | Standard Deviation 4.24 |
| Group 2 - 1.0 mg/2 mL | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Week 12 | -2.0 percentage of change from screening | Standard Deviation 4.58 |
| Group 2 - 1.0 mg/2 mL | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Day 7 | 0.0 percentage of change from screening | Standard Deviation 2 |
| Group 2 - 1.0 mg/2 mL | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Week 24 | 3.0 percentage of change from screening | Standard Deviation 12.12 |
| Group 3 - 2 mg/4 mL | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Day 7 | -1.0 percentage of change from screening | Standard Deviation 3 |
| Group 3 - 2 mg/4 mL | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Week 24 | 3.33 percentage of change from screening | Standard Deviation 11.93 |
| Group 3 - 2 mg/4 mL | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Week 12 | -1.33 percentage of change from screening | Standard Deviation 3.79 |
Secondary
Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging
Changes in Percentage of Left Ventricular Ejection Fraction by Cardiac Magnetic Resonance Imaging (MRI). Cardiac MRI will be used to monitor for the development of intramyocardial hemangiomas. Analysis will follow the standard cardiac MRI protocols of the Department of Radiology at Seoul National University Hospital, using an appropriate segment model based on the patient's heart size. Parameters evaluated will include left ventricular volume (mL), wall motion index, myocardial thickness (mm), and LVEF (%). Comparisons will be made between baseline/screening and follow-up measurements for each patient, as well as between treatment groups.
Time frame: Day 0, 12 weeks, 24 weeks
Population: Intent to Treat - Left Ventricular Ejection Percentage Fraction - Measured by Magnetic Resonance Imaging (MRI)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - 0.5 mg/1 mL | Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging | Week 12 | 1.77 percentage of change from screening | Standard Deviation 6.54 |
| Group 1 - 0.5 mg/1 mL | Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging | Week 24 | 0.45 percentage of change from screening | Standard Deviation 3.89 |
| Group 2 - 1.0 mg/2 mL | Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging | Week 12 | 1.63 percentage of change from screening | Standard Deviation 6.96 |
| Group 2 - 1.0 mg/2 mL | Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging | Week 24 | 6.80 percentage of change from screening | Standard Deviation 6.93 |
| Group 3 - 2 mg/4 mL | Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging | Week 12 | 2.67 percentage of change from screening | Standard Deviation 5.12 |
| Group 3 - 2 mg/4 mL | Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging | Week 24 | 0.13 percentage of change from screening | Standard Deviation 11.19 |