RecruitingPhase 1NCT06061549

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

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

Sponsor

Sardocor Corp.

Enrollment

10 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Preserved Ejection Fraction Heart Failure, Diastolic

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.

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a gene therapy to improve heart function in people with heart failure with preserved ejection fraction (HFpEF) — a type of heart failure where the heart pumps normally but becomes too stiff to fill properly. The therapy targets a protein called SERCA2a that helps the heart muscle relax. **You may be eligible if...** - You have heart failure with preserved ejection fraction (heart pumping function at or above 50%) - You have symptoms like shortness of breath with activity or elevated heart filling pressures - You are on oral diuretic (fluid-reducing) medication - You test negative for certain antibodies that would block the gene therapy delivery - You are using adequate birth control if applicable **You may NOT be eligible if...** - Your heart failure symptoms are very severe (NYHA Class IV) - You were hospitalized for heart failure in the past 3 months - You have atrial fibrillation, significant coronary artery disease, or congenital heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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