A Phase 12 Study Testing SRD-001 Gene Therapy Given by Coronary Infusion for Heart Failure With Reduced Ejection Fraction in Adults

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 IIIIV. The study aims to correct defective calcium regulation in heart muscle cells, which may improve heart function and blood flow. This Phase 12 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 11 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.

Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction