Targeting SERCA2a to improve heart function in patients with heart failure
A Phase 1/2 Trial of the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction
This study is testing a new treatment that uses a virus to help improve heart function in people with heart failure by correcting how calcium is handled in heart cells.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sardocor Corp. Industry-sponsored |
| Locations | 5 sites (San Diego, California and 4 other locations) |
| Trial ID | NCT04703842 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates the use of SRD-001, an adeno-associated virus vector designed to express the SERCA2a protein, in patients with heart failure with reduced ejection fraction (HFrEF). The trial consists of a Phase 1 open-label study to assess safety and dosing in a small group of participants, followed by a Phase 2 randomized, double-blind, placebo-controlled trial to evaluate efficacy in a larger cohort. The goal is to correct calcium handling in heart muscle cells, potentially improving heart function and blood flow. Participants will be monitored for clinical outcomes related to heart failure symptoms and overall cardiac performance.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic ischemic or non-ischemic cardiomyopathy, NYHA class III/IV symptoms, and an LVEF of 35% or less.
Not a fit: Patients with restrictive or hypertrophic cardiomyopathy, acute myocarditis, or those requiring immediate heart transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with HFrEF.
How similar studies have performed: While the approach of targeting SERCA2a is promising, it is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Main Inclusion Criteria: * Chronic ischemic or non-ischemic cardiomyopathy * NYHA class III/IV * LVEF ≤35% * Guideline-directed medical therapy for heart failure; ICD Main Exclusion Criteria: * Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm * Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), mechanical circulatory support device (MCSD) or cardiac shunt * Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment * Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability * Inadequate hepatic and renal function * Diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative
Where this trial is running
San Diego, California and 4 other locations
- San Diego Cardiac Center — San Diego, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Washington University in Saint Louis — St Louis, Missouri, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- University of Washington Medicine — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Coo
- Email: info@sardocorcorp.com
- Phone: 858-752-2941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.