YAP101 Gene Therapy for Heart Failure
(SALVADOR-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new gene therapy called YAP101 to assist individuals with heart failure resulting from a past heart attack. The goal is to determine if this treatment can safely enhance heart function by aiding in heart repair, reducing scarring, and improving pumping ability. Participants will receive a one-time treatment directly into the heart and will be monitored for a year to assess changes in heart health and daily life. The trial seeks adults with stable heart failure, experiencing symptoms like shortness of breath and fatigue for at least a year, who are unable to undergo certain heart surgeries. As a Phase 1 trial, this research aims to understand how YAP101 functions in people, offering participants the unique opportunity to be among the first to receive this innovative treatment.
Will I have to stop taking my current medications?
The trial requires participants to be on stable, maximally tolerated guideline-directed medical therapy for heart failure for at least 6 weeks before joining. This suggests you should continue your current heart failure medications unless advised otherwise by the study team.
Is there any evidence suggesting that YAP101 gene therapy is likely to be safe for humans?
Research shows that YAP101, a gene therapy for heart failure, has promising safety results in early studies. Patients generally tolerated the therapy well in these studies. Researchers have not observed any serious side effects related to the treatment. This is encouraging, especially since YAP101 remains in the early testing stages. Ongoing monitoring continues to ensure its safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about YAP101 for heart failure because it offers a novel approach through gene therapy. Unlike existing treatments like ACE inhibitors or beta-blockers, which manage symptoms by modifying heart function or blood pressure, YAP101 targets the underlying cellular processes. This gene therapy aims to enhance heart repair and regeneration by delivering the YAP101 gene directly to heart cells, potentially leading to more effective and lasting improvements in heart function. This innovative mechanism provides hope for tackling heart failure at its root, rather than just alleviating its symptoms.
What evidence suggests that YAP101 might be an effective treatment for heart failure?
Research has shown that YAP101 might help treat ischemic heart failure with reduced ejection fraction (HFrEF). It aids heart cell survival and reduces harmful changes in the heart. YAP101 employs gene therapy to target specific pathways that repair the heart, aiming to regrow heart muscle and enhance its function. Early results suggest this approach can repair damaged tissue, reduce scarring, and improve the heart's pumping ability. Although the data remains new, YAP101 offers hope for improving heart function in patients with limited treatment options. Participants in this trial will receive varying dosages of YAP101 to evaluate its effectiveness and safety.14567
Who Is on the Research Team?
Alexander Postalian, MD
Principal Investigator
Texas Heart Institute
Are You a Good Fit for This Trial?
Adults aged 18-80 with stable heart failure due to a past heart attack, showing specific symptoms for at least a year, and having certain levels of heart pumping function can join. They must be on steady heart failure medication for 6 weeks and not eligible for other heart procedures. Candidates should have adequate heart wall thickness, be able to undergo catheterization, agree to use contraception, and provide consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time transendocardial injection of YAP101 at one of three dose levels using an investigational cardiac injection catheter
Monitoring
Participants are monitored for safety and functional outcomes through a series of outpatient visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up (optional)
Participants have the option to enroll in a long-term follow-up study for up to 5 years
What Are the Treatments Tested in This Trial?
Interventions
- YAP101
Find a Clinic Near You
Who Is Running the Clinical Trial?
YAP Therapeutics, Inc.
Lead Sponsor