About this trial
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.
Eligibility criteria
Qualifiers
Willing and able to provide informed consent
Negative for anti-AAV1 neutralizing antibodies
NYHA class II or III
Left ventricular ejection fraction ≥ 50%
Disqualifiers
NYHA class IV
Heart failure requiring hospitalization in the past 3 months
Manifested or provocable ischemic heart disease
Atrial fibrillation
Trial design
Treatments tested in this trial
- AAV1/SERCA2a