RecruitingPhase 1Phase 2NCT04703842

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

A Phase 1/2 Trial of the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction

Sponsor

Sardocor Corp.

Enrollment

57 participants

Start Date

Sep 23, 2021

Study Type

INTERVENTIONAL

Conditions

Heart Failure Congestive Heart Failure HFrEF - Heart Failure With Reduced Ejection Fraction Heart Failure, Systolic

Summary

It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

Chronic ischemic or non-ischemic cardiomyopathy
NYHA class III/IV
LVEF ≤35%
Guideline-directed medical therapy for heart failure; ICD

Exclusion Criteria6

Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), mechanical circulatory support device (MCSD) or cardiac shunt
Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment
Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability
Inadequate hepatic and renal function
Diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative