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

NCTID	NCT06061549 (View at clinicaltrials.gov)
Description	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. (Show More)
Development Status	Active
Indication	Heart Failure With Preserved Ejection Fraction, Diastolic Heart Failure
Disease Ontology Term	DOID:9775
Compound Name	SRD-002
Compound Description	AAV1-CMV-SERCA2a
Sponsor	Sardocor Corp.
Funder Type	Industry
Recruitment Status	Recruiting (Click here for study contact information)
Enrollment Count	10 (ESTIMATED)
Results Posted	Not Available

Target Gene/Variant	SERCA2a
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Overexpression of protective allele/gene
Route of Administration	Intraarterial
Drug Product Type	Viral vector
Delivery System	Viral transduction
Vector Type	AAV1
Editor Type	none
Dose 1	3E13 vg
Dose 2	4.5E13 vg

Eligible Age	>=50 Years
Standard Ages	Adult, Older adult
Sexes Eligible for Study	ALL
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 View Inclusion and Exclusion Criteria at ClinicalTrials.gov

No.of Trial Sites	2
Locations	United States

Has US IND	True
FDA Designations	Fast Track
Recent Updates	Enrollment of Cohort B (4.5E13 vg) is complete