This study is testing an experimental gene therapy called AAV1/SERCA2a for people with a type of heart failure called heart failure with preserved ejection fraction (HFpEF), also known as diastolic heart failure. This condition means your heart can't relax properly to fill with enough blood. The study wants to see if AAV1/SERCA2a is safe and if it helps your heart's main pumping chamber (left ventricle) relax better during filling. You could be eligible if you are 50 or older, have NYHA class II or III heart failure, and your heart's pumping ability (ejection fraction) is 50% or higher. The main way they will measure success is by looking at changes in your pulmonary capillary wedge pressure (PCWP) at 24 and 52 weeks. The study is currently unclear on its recruitment status and plans to enroll 10 participants.

Study design

This is an interventional study, meaning participants will receive a treatment. It is a single-arm study, with a planned enrollment of 10 participants.

What's involved

You would receive a one-time infusion of the gene therapy. You would have multiple in-person visits during the first year, including assessments at weeks 2, 4, 12, 24, and 52, which involve tests like echocardiograms and heart catheterization. After the first year, you would have phone calls twice a year for 4 years.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for 52 weeks as part of the main trial, with primary endpoints measured at Week 24 and Week 52. After this, participants will continue to be followed for 4 years with bi-annual phone calls or in-person questionnaires.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.