Actively Recruiting
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Led by Sardocor Corp. · Updated on 2024-03-26
57
Participants Needed
5
Research Sites
375 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic ischemic or non-ischemic cardiomyopathy
- New York Heart Association (NYHA) class III or IV heart failure symptoms
- Left ventricular ejection fraction (LVEF) of 35% or less
- Receiving guideline-directed medical therapy for heart failure and have an implantable cardioverter defibrillator (ICD)
You will not qualify if you...
- Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or discrete left ventricular aneurysm
- Prior heart transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device use, mechanical circulatory support device, or cardiac shunt
- Likely to undergo cardiac resynchronization therapy, cardiomyoplasty, left ventricular reduction surgery, conventional revascularization, or valvular repair within 6 months after treatment
- Expected need for immediate heart transplant or mechanical circulatory support due to hemodynamic instability
- Inadequate liver or kidney function
- Diagnosis or treatment for any cancer within the last 5 years except basal cell carcinoma or carcinoma in situ treated with surgery alone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
San Diego Cardiac Center
San Diego, California, United States, 92123
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Washington University in Saint Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
University of Washington Medicine
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
C
COO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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