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New treatment option for Heart Failure With Reduced Ejection Fraction
Official title Study Assessing Left Ventricular Administration of a Genetic Medicine Directing Organ Regeneration in Heart Failure
ClinicalTrials.gov ID: NCT06831825
What this study is testing
What is YAP101 (AAV9-Sav-shRNA)?
YAP101 (AAV9-Sav-shRNA) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for heart failure with reduced ejection fraction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join 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...
- 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...
You likely can't join 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...
- 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;
See the full eligibility 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...
- 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.
- 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); people 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);
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.