Heart & Vascular Clinical Trials
A randomized, double-blinded, placebo-controlled study evaluating the efficacy and safety of ataciguat to slow the progression of valvular dysfunction in participants with moderate calcific aortic valve stenosis
Learn moreWhat is the purpose of this study?
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Eligibility
Key Inclusion Criteria:
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Adult male or female at least 50 years of age
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Has moderate CAVS as defined by:
- An AVA of ≥1.0 cm2 to ≤1.50 cm2
- An AVC score between >300 to 1200 Agatston units (AU) for women and between >300 to 2000 AU for men
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Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory
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For participants in CPET sub-study in Part A and all participants in Part B: If on beta blockade, the dose must be stable for at least 90 days prior to the Screening Visit with no anticipated changes during the study
- For participants in the CPET sub-study in Part A and all participants in Part B: Has any medical or physical condition that, in the Investigator's opinion, could lead to an inability to complete Protocol-required CPET procedures (eg, pulmonary disease, joint, leg, hip, back conditions that limit physical activity, or other absolute contraindications for CPET)
- Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
- Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
- Has suspected or known congenital aortic valve disease including bicuspid aortic valve
- New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes
- Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
- Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery
- Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants With Moderate Calcific Aortic Valve STenosis
- Disease Type/ConditionModerate Aortic Valve Stenosis
- Principal InvestigatorSubbarao Mylavarapu, MD
- Co-InvestigatorsGennie Yee, MD, Kevin Kheder, MD
- Age GroupAdult, Older Adult
- PhaseIII
- ClinicalTrials.gov IDNCT07001800
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Jeffrey M. Carlton Heart & Vascular Institute
Hoag’s Jeffrey M. Carlton Heart & Vascular Institute provides advanced, coordinated care for complex heart and vascular conditions, bringing together nationally recognized cardiologists, cardiac surgeons, electrophysiologists, heart failure specialists, and vascular experts. Patients have access to comprehensive evaluation, leading cardiovascular programs, advanced treatment options, and clinical trials designed to help identify the right path forward.
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