Actively Recruiting
Study Assessing Left Ventricular Administration of a Genetic Medicine Directing Organ Regeneration in Heart Failure
Led by YAP Therapeutics, Inc. · Updated on 2025-04-27
24
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Assessing Left Ventricular Administration of a Genetic Medicine Directing Organ Regeneration in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 79 years old
- Have medically stable ischemic heart failure due to a prior heart attack with NYHA class II or III symptoms for at least 12 months
- Have a left ventricular ejection fraction between 20% and 40% by cardiac MRI
- Not be a candidate for percutaneous coronary intervention or coronary artery bypass surgery as determined by study doctors
- Be on stable, maximally tolerated guideline-directed medical therapy for heart failure for at least 6 weeks, unless contraindicated
- Have left ventricular end diastolic wall thickness of at least 8 mm at the planned injection site
- Be a candidate for cardiac catheterization
- Agree to use contraception as required by the study
- Provide written informed consent
You will not qualify if you...
- Have valvular heart disease including mechanical or bioprosthetic heart valve or severe valve insufficiency within 12 months
- Have aortic stenosis with valve area 1.5 cm2 or less
- Have had a heart transplant, left ventricular reduction surgery, cardiomyoplasty, or passive restraint device
- Had an acute heart attack within 30 days before screening
- Have unstable angina within 30 days before screening
- Have non-ischemic cardiomyopathy such as idiopathic, valvular, or peri/post-partum types
- Have restrictive, obstructive, infiltrative cardiomyopathy, pericardial constriction, amyloidosis, or uncorrected thyroid disease
- Had an ischemic or hemorrhagic stroke within 90 days before screening
- Have liver dysfunction with enzymes more than three times normal
- Have a baseline kidney function (eGFR) less than 35 mL/min/1.73m2
- Have poorly controlled diabetes with HbA1c over 10%
- Have hematologic abnormalities at baseline
- Have coagulopathy with INR over 1.5 not due to reversible causes
- Have autoimmune disorders or are on immunosuppressive therapy
- Have contrast allergy that cannot be managed
- Previously received cell-based or viral vector gene therapy
- Have active systemic infection at time of treatment
- Have HIV, active hepatitis B or C, or active Covid-19 infection
- Have left ventricular thrombus
- Have pacemaker or ICD devices with certain restrictions including devices made before 2000, recent lead implantation, non-transvenous leads, subcutaneous ICDs, or MRI contraindications
- Have cardiac resynchronization therapy device implanted less than 3 months prior
- Have other MRI contraindications
- Have Mobitz II or higher degree AV block without a functioning pacemaker within 3 months
- Have history of drug or alcohol abuse within past 24 months
- Have cognitive or language barriers preventing consent or study participation
- Are currently or recently (within 30 days) participating in other cardiac investigational trials
- Are pregnant, lactating, planning pregnancy within 12 months, or unwilling to use birth control
- Expected survival less than 1 year
- Have active cancer within past 3 years except certain localized or treated cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Texas Heart Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Tyler H Kibbee, MBS
CONTACT
D
Director of Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here