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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Willing and able to provide willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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 myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm - History of amyloidosis - Untreated left-sided valvular disease - Severe COPD - BMI \> 50 kg/m\^2 - Severe liver, kidney or hematologic dysfunction - Cancer within the past 5 years - Unstable concurrent conditions Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm * History of amyloidosis * Untreated left-sided valvular disease * Severe COPD * BMI \> 50 kg/m\^2 * Severe liver, kidney or hematologic dysfunction * Cancer within the past 5 years * Unstable concurrent conditions

Treatments Being Tested

BIOLOGICAL

AAV1/SERCA2a

3E13 viral genomes fixed dose

Locations (2)

Duke University
Durham, North Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States