Status:
RECRUITING
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Lead Sponsor:
Sardocor Corp.
Conditions:
Congestive Heart Failure
Heart Failure, Systolic
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
MUSIC-HFrEF1 is an interventional study of SRD-001, an adeno-associated virus serotype 1 (AAV1) vector expressing the transgene for sarco(endo)plasmic reticulum Ca2+ ATPase 2a isoform (SERCA2a), in an...
Eligibility Criteria
Inclusion
- Main
- Chronic ischemic or non-ischemic cardiomyopathy
- NYHA class III/IV
- LVEF ≤35%
- Guideline-directed medical therapy for heart failure; ICD
- Main
Exclusion
- 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
Key Trial Info
Start Date :
September 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04703842
Start Date
September 23 2021
End Date
December 1 2028
Last Update
March 26 2024
Active Locations (5)
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1
San Diego Cardiac Center
San Diego, California, United States, 92123
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Washington University in Saint Louis
St Louis, Missouri, United States, 63110
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390