Actively Recruiting
A Phase 1/2 Trial of SRD-001 Gene Therapy for Heart Failure With Reduced Ejection Fraction
Led by Sardocor Corp. · Updated on 2024-03-26
57
Participants Needed
5
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of SRD-001, a gene therapy delivered by an adeno-associated virus vector, to treat patients with heart failure with reduced ejection fraction (HFrEF), including those with ischemic or non-ischemic cardiomyopathy and severe symptoms (NYHA class III/IV). The study aims to correct defective calcium regulation in heart muscle cells, which may improve heart function and blood flow. This Phase 1/2 trial evaluates the safety and effects of SRD-001 on heart failure symptoms and heart function. The trial includes two phases: an open-label Phase 1 testing two doses of SRD-001 given once via intracoronary infusion, and a randomized, double-blind Phase 2 comparing a single dose of SRD-001 to placebo in 50 participants. The infusion is administered one time, and participants are assigned to either SRD-001 or placebo in a 1:1 ratio during Phase 2. Participants will be followed for at least 12 months with evaluations of heart failure symptoms, physical function, heart remodeling, and rates of adverse or recurrent events. Assessments include laboratory tests, ECGs, physical exams, and device interrogations if applicable. The study monitors changes from baseline at 6 and 12 months to assess the impact of the treatment on clinical outcomes and safety.
CONDITIONS
Brief Title
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with chronic ischemic or non-ischemic cardiomyopathy
- New York Heart Association (NYHA) class III or IV symptoms
- Left ventricular ejection fraction (LVEF) of 35% or less
- Receiving guideline-directed medical therapy for heart failure
- Have an implantable cardioverter defibrillator (ICD)
You will not qualify if you...
- Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or discrete left ventricular aneurysm
- Prior heart transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device use, mechanical circulatory support device, or cardiac shunt
- Likely to receive cardiac resynchronization therapy, cardiomyoplasty, left ventricular reduction surgery, conventional revascularization, or valvular repair within 6 months after treatment
- Likely need for immediate heart transplant or mechanical circulatory support due to hemodynamic instability
- Inadequate liver or kidney function
- Diagnosis or treatment for any cancer within the last 5 years except basal cell carcinoma or carcinomas in situ treated with surgery alone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single administration with follow-up to 12 months
Participants receive a one-time intracoronary infusion of either SRD-001 gene therapy or placebo.
1 baseline visit and multiple follow-up visits up to 12 months
Trial Site Locations
Total: 5 locations
1
San Diego Cardiac Center
San Diego, California, United States, 92123
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Washington University in Saint Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
University of Washington Medicine
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
C
COO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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