A Phase 1b, Pilot Trial Evaluating the Safety and Pharmacodynamic Effects of SRD-001 (AAV1-SERCA2a) in Subjects With Heart Failure With Preserved Ejection Fraction
Sardocor Corp.
Summary
The goal of this clinical trial is to test an experimental gene therapy in participants with heart failure with preserved ejection fraction, also known as diastolic heart failure. The main questions it aims to answer are: * safety and tolerability of the gene therapy; and * whether the gene therapy helps the heart ventricles relax during filling. Participants will undergo a one-time infusion of the gene therapy in the cardiac catheterization laboratory and then be followed for safety and effects on left-sided filling pressures while exercising. The first year will have multiple in-person visits followed by 4 years of biannual phone calls.
Description
Eligible participants will undergo a one-time antegrade epicardial coronary artery infusion of gene therapy delivered to the 3 major cardiac territories of the left ventricle of the heart (anterior, lateral, inferior/posterior) or bypass grafts unless contraindicated. Post-procedure, the subject will be monitored continuously for a minimum of 4 hours and then discharged to home that same day if medically appropriate. Participants will be followed for 52 weeks as part of the main trial. On Day 2 and Week 1, subjects will be contacted by phone for a general safety assessment, and if clinically i…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willing and able to provide informed consent * Negative for anti-AAV1 neutralizing antibodies * NYHA class II or III * Left ventricular ejection fraction ≥ 50% * Evidence of resting or exercise-induced left ventricle filling pressure * On oral diuretic therapy * Adequate birth control Exclusion Criteria: * NYHA class IV * Heart failure requiring hospitalization in the past 3 months * Manifested or provocable ischemic heart disease * Atrial fibrillation * History of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute…
Interventions
- BiologicalAAV1/SERCA2a
3E13 viral genomes fixed dose
Locations (2)
- Duke UniversityDurham, North Carolina
- University of Texas Southwestern Medical CenterDallas, Texas