Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction (MUSIC-HFpEF)
Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction
About this trial
This is an interventional treatment trial for Heart Failure, Diastolic
Eligibility Criteria
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
Sites / Locations
- Duke UniversityRecruiting
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Experimental
SRD-001 Gene Therapy
AAV1/SERCA2a 3E13 vg