Tests a gene therapy for heart failure with preserved ejection fraction
Tests a gene therapy given once by infusion in people with diastolic heart failure.
Plain-language title generated from the registry record
Registry title: Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction
Key facts
- Where
- Dallas and Durham, United StatesSee the 2 sites
- Phase
- Phase 1
Where in United States
- University of Texas Southwestern Medical CenterDallas, United StatesNot yet recruiting
- Duke UniversityDurham, 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
- NCT06061549
- Record updated
- 29 September 2023
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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: Unstable concurrent conditions; Heart failure requiring hospitalization in the past 3 months; Manifested or provocable ischemic heart disease; History of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm; History of amyloidosis; Untreated left-sided valvular disease; Cancer within the past 5 years; NYHA class IV; Atrial fibrillation; Severe COPD; BMI > 50 kg/m\^2; Severe liver, kidney or hematologic dysfunction.