Taking peoplePhase 2/3
Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
Key facts
- Who runs it
- Kardigan, Inc.
- Where
- Brno, Brno-Stred, Brno-Zidenice, České Budějovice, and Prague, CzechiaSee the 5 sitesAlso in 8 other countries, 116 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 1,276 people, planned
- Started
- 27 Jun 2025
- Expected to end
- 30 Sept 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Ataciguat
- Placebo
- Record updated
- 6 July 2026
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Czechia
Also in 8 other countries, 116 sites
- Fakultni nemocnice BrnoBrno, CzechiaNot yet recruiting
- Fakultni Nemocnice U Sv Anny V BrneBrno-Stred, CzechiaNot yet recruiting
- Vojenska Nemocnice BrnoBrno-Zidenice, CzechiaNot yet recruiting
- Nemocnice České Budějovice, a.s.České Budějovice, CzechiaNot yet recruiting
- Vseobecna fakultni nemocnice v PrazePrague, CzechiaNot yet recruiting
About the trial
What the trial wants to find out
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
The 2 groups in the trial
- AtaciguatTreatment being tested
- PlaceboPlacebo, for comparison
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Publications
- Lipids and lipoproteins in calcific aortic valve disease.Current opinion in lipidology, 2026
- Record updated
- 6 July 2026