Targeting SERCA2a to improve heart function in patients with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the use of SRD-001, an adeno-associated virus vector designed to express the SERCA2a protein, in patients with heart failure with reduced ejection fraction (HFrEF). The trial consists of a Phase 1 open-label study to assess safety and dosing in a small group of participants, followed by a Phase 2 randomized, double-blind, placebo-controlled trial to evaluate efficacy in a larger cohort. The goal is to correct calcium handling in heart muscle cells, potentially improving heart function and blood flow. Participants will be monitored for clinical outcomes related to heart failure symptoms and overall cardiac performance.

Why it matters

Who can join: the full rules

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

Where it's running

• San Diego Cardiac Center
  San Diego, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Washington University in Saint Louis
  St Louis, Missouri, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• University of Washington Medicine
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Coo
• Email: info@sardocorcorp.com
• Phone: 858-752-2941

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

• Community-informed approaches to equitable heart failure care in primary care

  This study tests whether engaging patients, caregivers, community health workers, and care teams can help Mayo Clinic develop equity-focused, practical care strategies for adults with congestive heart failure who face social challenges.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07730827

• LY3971297 in heart failure: safety and tolerability in HF with preserved and reduced ejection fraction

  This study tests how well LY3971297 is tolerated and what side effects occur in people with HFpEF or HFrEF.

  Recruiting Phase 1 Eli Lilly and Company · Detroit, Michigan and 11 other locations · NCT07547540

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Exploring heart failure and diabetes interactions

  This study looks at how heart failure and diabetes affect the body differently by testing 600 people with various combinations of these conditions.

  Recruiting University of Leeds · Leeds, West Yorkshire · NCT06774014

• AI-based assessment of heart function using ECG wearable monitors

  This study tests if a new AI tool using a wearable heart monitor can accurately check heart function in people with heart failure compared to traditional heart scans.

  Recruiting at 8 sites Peerbridge Health, Inc · Orange, California and 7 other locations · NCT06699056

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.