Is NCT06831825 recruiting in Houston, TX?

Yes, NCT06831825 is currently recruiting participants at its Houston, TX location. This heart failure with reduced ejection fraction clinical trial is actively enrolling qualified participants.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Heart Failure With Reduced Ejection Fraction Clinical Trial in Houston, TX

Q: How do I join the heart failure with reduced ejection fraction clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Heart Failure With Reduced Ejection Fraction Study in Houston

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.

Sponsor: YAP Therapeutics, Inc.

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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

subcutaneous ICDs

any other condition that, in the judgment of device-trained staff, would deem an MRI contraindicated;

A cardiac resynchronization therapy (CRT) device implanted \< 3 months prior to consent;

Other MRI contraindications

Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent;

A history of drug abuse or alcohol abuse, or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months;

Cognitive or language barriers that prohibit obtaining informed consent or any study elements;

Participation (currently or within the previous 30 days) in a cardiac related investigational therapeutic (including stem cell and gene-based therapies) or device trial;

Pregnancy, lactation, plans to become pregnant in the next 12 months, or is unwilling to use acceptable forms of birth control during study participation;

Expected survival \< 1 year in the judgment of the investigator;

Active malignancy within the past 3 years (exceptions: localized prostate cancer, cervical or breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated);

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT06831825) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure With Reduced Ejection Fraction Treatment Options in Houston, TX

If you're searching for heart failure with reduced ejection fraction treatment options in Houston, TX, this clinical trial (NCT06831825) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure with reduced ejection fraction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure with reduced ejection fraction clinical trials near you to find additional studies recruiting in your area.

Heart Failure With Reduced Ejection Fraction Clinical Trial in Houston, TX

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