Tests SRD-001 gene therapy in adults with heart failure with reduced ejection fraction
Tests SRD-001, a gene therapy, against placebo in adults with weakened-heart failure.
Plain-language title generated from the registry record
Registry title: Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Key facts
- Where
- Dallas, San Diego, San Francisco, Seattle, and St Louis, United StatesSee the 5 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04703842, who can take part
Where in United States
- University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- San Diego Cardiac CenterSan Diego, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- University of Washington MedicineSeattle, United StatesTaking people
- Washington University in Saint LouisSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sardocor Corp.
- Trial code
- NCT04703842
- Record updated
- 26 March 2024
- Original description
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.Read full original descriptionShow less
A Phase 1/2 Trial of the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction
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.
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.