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Clinical Trial NCT07496372 (REVIVE-HEART) for Heart Failure is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV) (REVIVE-HEART) Phase 3 80

Not yet recruiting
Clinical Trial NCT07496372 (REVIVE-HEART) is designed to study Treatment for Heart Failure. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on April 30, 2026 until the study accrues 80 participants. Led by Help Therapeutics, this study is expected to complete by August 31, 2027. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
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 immunosuppre...Show More
Official Title

Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)

Conditions
Heart Failure
Other Study IDs
  • REVIVE-HEART
  • Liu XC
NCT ID Number
NCT07496372
Start Date (Actual)
2026-04-30
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-08-31
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
Advanced heart failure
HiCM188
HiCM-188
REVIVE-HEART
cardiomyocyte
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorControl group
Coronary artery bypass grafting surgery
CABG surgery
Conventional coronary artery bypass grafting (CABG) surgery
ExperimentalExperimental group
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
HiCM-188 therapy
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
CABG surgery
Conventional coronary artery bypass grafting (CABG) surgery
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
6-minute walk distance (6MWD)
12 months after surgery
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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)
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.
12 months after surgery
Change from baseline in the SF-36 questionnaire
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.
12 months after surgery
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
Left ventricular ejection fraction
12 months after surgery
Cardiac Volumes as assessed by MRI
Left ventricular end-diastolic volume index (LVEDVi), Left ventricular end-systolic volume index (LVESVi) and Stroke Volume (SV)
12 months after surgery
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

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.
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