Clinical Trials in the USA / NCT04703842
Recruiting
Phase 1/2
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
NCT04703842 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Congestive Heart FailureHeart Failure, SystolicHeart FailureHFrEF - Heart Failure With Reduced Ejection Fraction
Investigational drug(s) / intervention(s)
SRD-001Placebo
SRD-001: AAV1/SERCA2a
Placebo: SRD-001 matching placebo
Study summary
It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.
Eligibility
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
Primary outcome measure(s)
- Change from baseline in symptomatic parameters — Baseline to Month 6 and Month 12
New York Heart Association classification (I, II, III or IV) - Change from baseline in symptomatic parameters — Baseline to Month 6 and Month 12
Quality of life as assessed by Kansas City Cardiomyopathy Questionnaire: 0-24, very poor to poor; 25-49, poor to fair; 50-74, fair to good; and 75-100, good to excellent - Change from baseline in physical parameter — Baseline to Month 6 and Month 12
Distance walked during the 6MWT - Change from baseline in LV function/remodeling — Baseline to Month 6 and Month 12
Left ventricular end systolic volume (LVESV) as assessed by echocardiography - Rate of recurrent events — Baseline to Month 6 and Month 12
HF-related hospitalization, ambulatory worsening heart failure, all-cause death, MCSD and transplant - Rate of adverse events — 6 and 12 months
Treatment-emergent adverse events
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| San Diego Cardiac Center | San Diego | California | Recruiting |
| University of California, San Francisco | San Francisco | California | Recruiting |
| Washington University in Saint Louis | St Louis | Missouri | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| University of Washington Medicine | Seattle | Washington | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04703842 on ClinicalTrials.gov ↗ ← All trials in the USA