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

Recruiting now · Phase 1

Conditions studied: Heart Failure With Reduced Ejection Fraction

In brief

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.

Key facts

Study ID

NCT06831825

Run by

YAP Therapeutics, Inc.

People needed

24

Starts

2025-04-23

Expected to finish

2027-06-01

Last updated by the study team

2025-04-27

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To participate, a subject MUST:
• Be ≥ 18 and < 80 years of age;
• Have medically stable heart failure of ischemic etiology, secondary to MI with NYHA class II or III symptoms for at least 12 months before the initiation of screening procedures;
• Have a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 40% by cMRI at screening and baseline;
• The subject is not a candidate for either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery as determined by the principal investigator (or designee) in consultation with an interventional cardiologist during the screening period;
• Be on stable, outpatient, maximally tolerated guideline directed medical therapy (GDMT) for HF for 6 weeks, unless contraindicated, and remain stable during the screening period;
• Left ventricular (LV) end diastolic wall thickness of at least 8mm at the potential myocardial site for injection;
• Be a candidate for cardiac catheterization;
• Agree to protocol defined requirements for contraception;
• Provide written informed consent.

You may not qualify if…

• To participate, a subject MUST NOT HAVE:
• Valvular heart disease including 1) mechanical or bioprosthetic heart valve; or 2) severe valvular (any valve) insufficiency/regurgitation within 12 months of consent;
• Aortic stenosis with valve area ≤ 1.5cm2;
• Prior heart transplant, history of LV reduction surgery, cardiomyoplasty, passive restraint device
• Had an acute myocardial infarction within the prior 30 days before initiation of screening;
• Unstable angina pectoris within 30 days before initiation of screening procedures;
• Idiopathic, valvular, peri/post-partum cardiomyopathy or other cardiomyopathy of non-ischemic etiology;
• Restrictive, obstructive, or infiltrative cardiomyopathy; pericardial constriction; amyloidosis; or uncorrected thyroid disease;
• A history of ischemic or hemorrhagic stroke within 90 days of screening;
• Liver dysfunction, as evidenced by enzymes (e.g., AST, ALT, alkaline phosphatase) greater than 3 times upper limit of normal;
• A baseline eGFR <35 mL/min/1.73m2;
• Diabetes with poorly controlled blood glucose levels (HbA1c > 10%);
• A hematologic abnormality during baseline testing;
• Coagulopathy (INR > 1.5) not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors); Subjects who cannot be withdrawn from anticoagulation will be excluded;
• An underlying autoimmune disorder or current immunosuppressive therapy;
• A contrast allergy that cannot adequately be managed by premedication;
• Received cell-based therapy from any source;
• Received any viral vector mediated gene therapy;
• Evidence of active systemic infection at time of study product delivery;
• HIV and/or active HBV, HCV or Covid-19 infection at screening or baseline;
• Presence of LV thrombus;
• Presence of a pacemaker or ICD generator with any of the following limitations/conditions:
• manufactured before the year 2000
• leads implanted < 6 weeks prior to screening
• non-transvenous epicardial leads

Where it is running

• Texas Heart Institute — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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