Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Recruiting · NCT04703842 · Interventional (participants receive a specific treatment) · Lead sponsor: Sardocor Corp.
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSRD-001
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
5 locations listed across 4 US states.
- San Diego Cardiac Center - San Diego, California, United States
- University of California, San Francisco - San Francisco, California, United States
- Washington University in Saint Louis - St Louis, Missouri, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- University of Washington Medicine - Seattle, Washington, United States