Congestive Heart Failure study: SRD-001
Official title Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
ClinicalTrials.gov ID: NCT04703842
What this study is testing
What is SRD-001?
an investigational biological therapy being studied for congestive heart failure with reduced ejection fraction is designed to deliver a gene that produces the SERCA2a enzyme to heart cells, aiming to improve calcium handling and cardiac contractility
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if replacing the SERCA2a enzyme improves heart muscle contraction and blood flow in HFrEF patients.
- Who it's for
- Adults diagnosed with heart failure with reduced ejection fraction.
- What's involved
- Participants will receive the SERCA2a enzyme replacement and have regular check‑ups and heart tests.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Main
- Chronic ischemic or non-ischemic cardiomyopathy
- NYHA class III/IV
- LVEF ≤35%
- Guideline-directed medical therapy for heart failure; ICD Main
You likely can't join if
- Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy...
- Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support...
- Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- San Francisco, California, United States
- St Louis, Missouri, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; San Francisco, California, United States; St Louis, Missouri, United States; Dallas, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.