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

Launched by SARDOCOR CORP. · Jan 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment aimed at helping patients with a specific type of heart failure called Heart Failure with Reduced Ejection Fraction (HFrEF). Researchers believe that by replacing a faulty enzyme known as SERCA2a, they can help improve the way calcium moves in heart cells. This may enhance the heart's ability to pump blood effectively and improve overall heart function. The trial is looking for participants who are between 65 and 75 years old and have chronic heart issues that are not responding well to standard treatments.

To be eligible for this trial, participants should have a specific level of heart function (an LVEF of 35% or less) and be experiencing significant symptoms of heart failure. However, certain conditions, such as restrictive cardiomyopathy or recent heart surgeries, would exclude someone from participating. If eligible, patients can expect to receive the new treatment and be monitored closely for any changes in their heart function and overall health. This trial is currently recruiting participants, and it's an opportunity for those struggling with heart failure to potentially access a new approach to their treatment.

Gender

ALL

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