Heart Failure
Conditions
Keywords
Advanced heart failure, HiCM188, HiCM-188, REVIVE-HEART, cardiomyocyte
Brief summary
The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)
Detailed description
REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppressive therapy. Efficacy and safety were assessed 12 months post-treatment.
Interventions
BIOLOGICALHiCM-188 therapy
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
PROCEDURECABG surgery
Conventional coronary artery bypass grafting (CABG) surgery
Sponsors
HELP Therapeutics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 75 years, regardless of gender; 2. Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT); 3. LVEF ≤ 35% as measured by cardiac MRI; 4. Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery; 5. Voluntary participation and signing of the informed consent form.
Exclusion criteria
Patients considered for this trial must not meet any of the following criteria: 1. Acute viral myocarditis; 2. Acute phase of myocardial infarction (≤ 3 months); 3. Cardiac amyloidosis; 4. Pericarditis; 5. Expected to undergo heart transplantation; 6. Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test; 7. Suffering from autoimmune diseases; 8. Estimated glomerular filtration rate (eGFR) \< 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 100 U/L; 9. Presence of any untreated precancerous lesions or those requiring active monitoring; 10. Occurrence of malignant tumors within 5 years prior to screening; 11. Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation); 12. Having contraindications to the use of immunosuppressants; 13. Having contraindications to MRI; 14. Having contraindications to CABG surgery; 15. Females who are pregnant, lactating, or have a positive blood pregnancy test; 16. Plans to conceive within one year; 17. Having systemic diseases that are not effectively controlled; 18. Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walk distance (6MWD) | 12 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality and cardiovascular mortality | 12 months after surgery | — |
| 6MWD | 6 months after surgery | — |
| Change from baseline in the NYHA classification | 12 months after surgery | — |
| Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure) | 12 months after surgery | — |
| Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) | 12 months after surgery | The MLHFQ is a self-administered disease-specific outcome measure instrument for patients with heart failure (HF), comprising 21 items rated on Likert scales, representing different degrees of impact of HF on QoL. The MLHFQ scores are on a range of 0-105, in which lower scores reflect better health status. |
| Change from baseline in the SF-36 questionnaire | 12 months after surgery | The 36-Item Short Form Survey(SF-36) is a self-administered outcome measure instrument that comprises 36 items grouped into 8 dimensions: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health, limitations in usual role activities because of emotional problems, vitality, general health perceptions. The SF-36 scores are on a range of 0-100, in which higher scores reflect better health status. |
| Myocardial blood flow as assessed by SPECT | 12 months after surgery | — |
| Myocardial viability as assessed by SPECT | 12 months after surgery | — |
| Left ventricular ejection fraction as assessed by MRI | 12 months after surgery | Left ventricular ejection fraction |
| Cardiac Volumes as assessed by MRI | 12 months after surgery | Left ventricular end-diastolic volume index (LVEDVi), Left ventricular end-systolic volume index (LVESVi) and Stroke Volume (SV) |
| Scar size as assessed by MRI | 12 months after surgery | — |
| Change from baseline in NT-proBNP level | 12 months after surgery | — |
| Tumor markers abnormally elevated compared to baseline | 12 months after surgery | — |
| Other AEs | 12 months after surgery | — |
Countries
China
Outcome results
None listed