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

RecruitingPhase 1, Phase 2Ages 18 Years - 80 YearsAllSardocor Corp.
NCT04703842 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Main Inclusion Criteria: * Chronic ischemic or non-ischemic cardiomyopathy * NYHA class III/IV * LVEF ≤35% * Guideline-directed medical therapy for heart failure; ICD Main Exclusion Criteria: * 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
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What it tests

  • SRD-001
  • Placebo
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Where

5 sites
San Diego Cardiac Center
San Diego, United States
University of California, San Francisco
San Francisco, United States
Washington University in Saint Louis
St Louis, United States
University of Texas Southwestern Medical Center
Dallas, United States
University of Washington Medicine
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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