Taking peoplePhase 2/3
Ataciguat compared with placebo for moderate calcific aortic valve stenosis
Tests whether ataciguat slows moderate calcific aortic valve stenosis in adults.
Key facts
- Who runs it
- Kardigan, Inc.
- Where
- Arendal, Graalum, Loerenskog, Stavanger, and Trondheim, NorwaySee the 5 sitesAlso in 8 other countries, 116 sites
- Trial code
- Registry title
- Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
- 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
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 or older with moderate calcific aortic valve stenosis. This is a narrowing of the heart's aortic valve caused by calcium build-up.
- Age
- 50 years and older
- Sex
- Men and women
- Disease stage
- Moderate calcific aortic valve stenosis: valve opening area (AVA) of ≥1.0 cm2 to ≤1.50 cm2. Valve calcium score (AVC) between >300 to 1200 Agatston units (AU) for women and >300 to 2000 AU for men. Heart pumping strength (ejection fraction) of ≥45% on heart ultrasound.
- Earlier treatment
- In the exercise test sub-study of Part A and all of Part B: people taking a beta blocker must be on a stable dose for at least 90 days before screening, with no changes planned.
Main reasons for not taking part
- Aortic valve replacement, repair, surgery or other valve procedure expected or planned in the next 6 months
- Moderate or worse (Grade 2 or higher) mitral stenosis, mitral regurgitation or aortic regurgitation
- Aortic valve disease present from birth, including bicuspid aortic valve
- NYHA Class IV heart failure symptoms or a need for continuous inotropes (heart-strengthening drugs)
- Untreated blocked heart arteries, abnormal ECG, or long-standing persistent or permanent atrial fibrillation
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 Norway
Also in 8 other countries, 116 sites
- Sorlandet Sykehus HFArendal, NorwayNot yet recruiting
- Sykehuset Ostfold HFGraalum, NorwayNot yet recruiting
- Akershus University HospitalLoerenskog, NorwayNot yet recruiting
- Helse Stavanger HFStavanger, NorwayNot yet recruiting
- St. Olavs hospital HFTrondheim, NorwayNot 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
- Plain-language title
- Ataciguat compared with placebo for moderate calcific aortic valve stenosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Publications
- Lipids and lipoproteins in calcific aortic valve disease.Current opinion in lipidology, 2026
- Record updated
- 6 July 2026