Gene therapy for heart failure with preserved ejection fraction

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 clinical trial aims to evaluate the safety and effectiveness of an experimental gene therapy targeting SERCA2a in patients with heart failure with preserved ejection fraction. Participants will receive a one-time infusion of the gene therapy directly into the heart and will be monitored for safety and changes in heart function during exercise. The study includes multiple follow-up visits in the first year and biannual assessments over the next four years to track overall health and heart performance. The trial seeks to determine if the therapy can improve the heart's ability to relax and fill with blood.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willing and able to provide informed consent
* Negative for anti-AAV1 neutralizing antibodies
* NYHA class II or III
* Left ventricular ejection fraction ≥ 50%
* Evidence of resting or exercise-induced left ventricle filling pressure
* On oral diuretic therapy
* Adequate birth control

Exclusion Criteria:

* NYHA class IV
* Heart failure requiring hospitalization in the past 3 months
* Manifested or provocable ischemic heart disease
* Atrial fibrillation
* History of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
* History of amyloidosis
* Untreated left-sided valvular disease
* Severe COPD
* BMI \> 50 kg/m\^2
* Severe liver, kidney or hematologic dysfunction
* Cancer within the past 5 years
* Unstable concurrent conditions

Where it's running

• Duke University
  Durham, North Carolina, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Not yet recruiting

Study contacts

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

Similar studies

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

• Incretin therapy with tirzepatide for obesity-related HFpEF

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• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• EDG-15400 in adults with HFpEF: a phase 2 study

  This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.

  Recruiting at 4 sites Phase 2 Edgewise Therapeutics, Inc. · Birmingham, Alabama and 27 other locations · NCT07795814

• 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

• Boosted exercise with group coaching for HFpEF

  This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07413198

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.