Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
Key facts
- Where
- A Coruña, Barcelona, Murcia, Sevilla, and Vigo, SpainSee the 6 sites
- Phase
- Phase 2/3
Where in Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainNot yet recruiting
- Hospital Universitari Vall d'HebronBarcelona, SpainNot yet recruiting
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpainNot yet recruiting
- Futuremeds Spain S.L.Sevilla, SpainNot yet recruiting
- Hospital Universitario Virgen De La MacarenaSevilla, SpainNot yet recruiting
- Complexo Hospitalario Universitario De VigoVigo, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Kardigan, Inc.
- Trial code
- NCT07001800EU 2025-522176-86-01
- Record updated
- 6 July 2026
- Original description
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.Read full original descriptionShow less
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
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Inclusion: Adult male or female at least 50 years of age; 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; Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory; 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.
Exclusion: Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months; 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); 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; Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation; Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation.