NCT04703842 Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
| NCT ID | NCT04703842 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sardocor Corp. |
| Condition | Congestive Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2021-09-23 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 57 participants in total. It began in 2021-09-23 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04703842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Congestive Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04703842 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04703842 currently recruiting?
Yes, NCT04703842 is actively recruiting participants. Contact the research team at info@sardocorcorp.com for enrollment information.
Where is the NCT04703842 trial being conducted?
This trial is being conducted at San Diego, United States, San Francisco, United States, St Louis, United States, Dallas, United States and 1 additional location.
Who is sponsoring the NCT04703842 clinical trial?
NCT04703842 is sponsored by Sardocor Corp.. The trial plans to enroll 57 participants.
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