RecruitingPhase 1NCT06831825

Study Assessing Left Ventricular Administration of a Genetic Medicine Directing Organ Regeneration in Heart Failure

A Phase I Study of Safety and Preliminary Efficacy of YAP101 in Subjects With Ischemic Heart Failure and Reduced Ejection Fraction

Sponsor

YAP Therapeutics, Inc.

Enrollment

24 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Reduced Ejection Fraction

Summary

This clinical trial investigates the safety and preliminary effectiveness of YAP101, a gene therapy designed to improve heart function in adults with ischemic heart failure and reduced ejection fraction (HFrEF). Ischemic heart failure, often resulting from a prior heart attack, leads to poor heart function and quality of life. Current treatments are limited, and there is an urgent need for new therapies. YAP101 works by delivering a gene therapy using a specialized vector to heart cells, targeting a pathway involved in heart repair. By temporarily activating heart muscle regeneration, YAP101 aims to restore damaged tissue, reduce scarring, and improve the heart's pumping ability. The study will enroll participants who will receive a one-time dose of YAP101 via a minimally invasive cardiac injection. Researchers will monitor participants over 12 months to assess safety and changes in heart function, exercise tolerance, and quality of life.

Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new gene therapy injected directly into the heart's left ventricle to try to promote heart muscle regeneration in patients with stable heart failure caused by a previous heart attack. The goal is to see if delivering this genetic medicine to the heart can improve how well the heart pumps. **You may be eligible if...** - You are between 18 and 80 years old - You have stable heart failure resulting from a past heart attack, with symptoms for at least 12 months - Your heart pumping function (ejection fraction) is between 20% and 40% - You have been on the maximum tolerated heart failure medications for at least 6 weeks - You are not a candidate for stenting (PCI) or bypass surgery (CABG) **You may NOT be eligible if...** - Your heart failure is due to causes other than a heart attack - Your symptoms are too severe or unstable - You are eligible for or have had heart surgery that could address the underlying problem Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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