Heart Failure, Heart Failure At NYHA Stage III or IV
Conditions
Keywords
LVAD, CABG, iPSC-CMs
Brief summary
This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.
Interventions
BIOLOGICALlow dose CABG+iPSC-CMs
CABG+0.5×10\^8 iPSC-CMs
BIOLOGICALHigh dose CABG/LVAD+iPSC-CMs
CABG+1.5×10\^8 iPSC-CMs or LVAD+1.5×10\^8 iPSC-CMs
OTHERCABG/LVAD+Saline
CABG/LVAD+Saline
Sponsors
Help Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 35-75 years (inclusive) at the time of signing the informed consent form. * Capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form. * Diagnosed with end-stage heart failure. * Receiving optimized medical therapy for heart failure, with New York Heart Association (NYHA) functional class III-IV. * Echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall. * Cardiac magnetic resonance imaging (MRI) confirming left ventricular ejection fraction (LVEF) ≤35%. * Myocardial perfusion-metabolism imaging with radionuclide indicating infarcted myocardium in the left anterior descending (LAD) artery territory. * Meets criteria for coronary artery bypass grafting (CABG) under cardiopulmonary bypass during screening and requires CABG surgery. * For patients enrolled in the LVAD implantation group, the following additional criteria must be met: 1. Definitive indication for LVAD implantation due to end-stage heart failure. 2. Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection. 3. Absence of significant contraindications for LVAD surgery.
Exclusion criteria
* History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT). * Severe valvular heart disease. * Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening. * Non-ischemic cardiomyopathy or acute viral myocarditis. * Acute cerebrovascular event within 1 month prior to screening. * History of malignancy within 5 years prior to screening. * Autoimmune disease or chronic use of immunosuppressive agents. * History of organ transplantation. * Planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure/resection). * Malignant ventricular arrhythmia. * Contraindications for CABG surgery. * Positive serology for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody. * Inability to undergo cardiac MRI or PET/CT imaging. * Contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen. * Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate/methylprednisolone, other corticosteroids, or basiliximab. * Participation in another clinical trial within 3 months prior to screening. * Pregnancy, lactation, or positive pregnancy test in female patients. * Any other condition deemed by the investigator to render the patient unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test | baseline, 1, 3, 6, 12 months post-operation | — |
| Major Adverse Cardiovascular Events | From enrollment to the end of study at 12 months | The composite endpoint events occurring during the prescribed postoperative follow-up period included cardiac death, non-fatal myocardial infarction, non-fatal stroke, and emergency target vessel revascularization (e.g., PCI or CABG), which was expressed as the percentage of subjects experiencing at least one of these events (%). |
| Survival rate | From enrollment to the end of study at 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 | baseline, 1, 3, 6, 12 months post-operation | life quality assessed by SF-36 (The Short-Form-36 Health Survey). The SF-36 scale is a tool used to assess health-related quality of life, including eight dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Each dimension has its unique scoring criteria, and the score range for each dimension is from 0 to 100 points. Higher scores indicate better health outcomes |
| Left ventricular ejection fraction | baseline, 1, 3, 6, 12 months post-operation | Improvement of left ventricular ejection fraction assessed by ECHO |
| Removal rate of LVAD | From enrollment to the end of study at 12 months | Percentage of subjects who had their Left Ventricular Assist Device (LVAD) successfully removed after surgery |
| KCCQ | baseline, 1, 3, 6, 12 months post-operation | Kansas City Cardiomyopathy Questionnaire, KCCQ is designed to assess the health status and quality of life of patients with heart failure. The score range is from 0 to 100 and higher scores reflect better health status and quality of life. |
| Cardiac magnetic resonance detection index | baseline, 1, 3, 6, 12 months post-operation | Myocardial infarction size and Myocardial fibrosis assessed by MRI |
| BNP | baseline, 1, 3, 6, 12 months post-operation | BNP levels are measured by venous blood samples |
Countries
China
Contacts
Primary ContactJiaxian Wang, MD, PhD
Outcome results
None listed