Moderate Aortic Valve StenosisPhase 2/3KATALYST-AVNCT07001800
Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
A Phase 2/3 study testing Ataciguat in people with Moderate Aortic Valve Stenosis, run by Kardigan, Inc. at 74 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Moderate Aortic Valve Stenosis
- What is being tested?
- Ataciguat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,276 participants
- Where
- 74 sitesin 2 countries
- Study dates
- 27 Jun 2025to 30 Sep 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
74 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
74 sites in 2 countries
United States70 sites, 69 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
HCA Florida - JFK Hospital
Atlantis, Florida, 33462
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
St. David's Heart and Vascular dba Austin Heart - Main Office
Austin, Texas, 78705
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
National Heart Institute
Beverly Hills, California, 90211
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of Alabama at Birmingham (UAB) - Medical Center
Birmingham, Alabama, 35233
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Withdrawn
University of Buffalo
Buffalo, New York, 14203
- Not yet recruiting
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, 08103
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, 60611
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Bethesda North Hospital, TriHealth, Inc
Cincinnati, Ohio, 45242
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Duke University School of Medicine
Durham, North Carolina, 27710
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Ascension Heart and Vascular/Alexian Brothers Heart & Vascular Institute
Elk Grove Village, Illinois, 60007
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, 46514
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Sanford Fargo
Fargo, North Dakota, 58122
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
NorthShore University Health System
Glenview, Illinois, 60026
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina, 27401
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
New Generation of Medical Research
Hialeah, Florida, 33016
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Memorial Healthcare System
Hollywood, Florida, 33021
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
University of Texas Medical Branch - Galveston
Houston, Texas, 77555
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Heart Center Research LLC
Huntsville, Alabama, 35801
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Riverside Medical Center - Illinois
Kankakee, Illinois, 60901
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Penn Medicine Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of Louisville Health
Louisville, Kentucky, 40202
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
University of Miami
Miami, Florida, 33136
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Cardiovascular Medicine
Moline, Illinois, 61265
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, 85831
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Inspira Medical Centers
Mullica Hill, New Jersey, 08062
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Midwest Cardiovascular Institute
Naperville, Illinois, 60540
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
New Generation of Medical Research - Naples
Naples, Florida, 34116
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
The Heart Hospital at Deaconess Gateway
Newburgh, Indiana, 47630
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Profound Research LLC at Southern California Heart Specialists
Pasadena, California, 91105
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Mayo Clinic - Phoenix
Phoenix, Arizona, 85259
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Baylor Scott and White - The Heart Hospital Baylor Plano
Plano, Texas, 75093
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
OnSite Clinical Solutions, LLC - Rock Hill
Rock Hill, South Carolina, 29732
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Corewell Health
Royal Oak, Michigan, 48073
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Flourish Research - St. Augustine
Saint Augustine, Florida, 32086
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of Utah Hospital & Clinics
Salt Lake City, Utah, 84112
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Methodist Hospital - San Antonio
San Antonio, Texas, 78229
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of California, San Francisco (UCSF) - Medical Center
San Francisco, California, 94143
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Washington University
St Louis, Missouri, 63110
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, 77479
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
University of South Florida
Tampa, Florida, 33606
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, 90502
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Ascension St. John Hospital
Tulsa, Oklahoma, 74104
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Inspira Medical Center of Vineland
Vineland, New Jersey, 08302
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Henry Ford Hospital
West Bloomfield, Michigan, 48322
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
Canada4 sites, 4 recruiting
- Recruiting
Montreal Heart Institute - Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
Centre Hospitalier de l Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C1
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, Quebec, GIV 4G5
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
- Not yet recruiting
St. Boniface Hospital
Winnipeg, Mantioba, R2H 2A6
Kardigan Clinical Study Information Team, 1-877-310-5135, clinicaltrials@kardigan.bio
About this study
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
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Read the detailed description
This study will be conducted in two parts: Part A and Part B. The purpose of Part A is to investigate whether ataciguat slows the progression of aortic valve calcium (AVC) deposition in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. Approximately 132 participants will be enrolled in Part A. Enrollment in Part B will begin once enrollment in Part A is complete. The purpose of Part B is to investigate whether ataciguat slows the rate of aortic valve area (AVA) loss and to evaluate the effect of ataciguat on peak oxygen consumption (VO2) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated. Approximately 1144 participants will be enrolled in Part B.
- Conditions
- Moderate Aortic Valve Stenosis
- Being tested
- Ataciguat, Placebo
- Keywords
- Ataciguat, sGC activator, sGC stimulator, Aortic valve stenosis, Moderate aortic valve stenosis, Calcific aortic valve stenosis, CAVS, Moderate Calcific Aortic Valve Stenosis, Aortic Stenosis (AS)
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaciguatDrug
Ataciguat will be administrated daily for up to 156 weeks
PlaceboDrug
Placebo will be administrated daily for up to 156 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ataciguat | Experimental | Not described Receives: Drug: Ataciguat |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24
Measured: Week 24
(Part B Dual-Primary) Percent change in Aortic Valve Area (AVA) as measured by echocardiogram from baseline to Week 48
Measured: Week 48
(Part B Dual-Primary) Change in peak VO2 by CPET from baseline to Week 48
Measured: Week 48
Secondary outcomes (8)
(Part A) Correlation in the change in AVC as assessed by non-contrast CT and change in VO2 at Week 48
Measured: Week 48
(Part A) Change in VO2 from baseline to Week 48
Measured: Week 48
Change in left ventricular diastolic function as assessed by E/e' from baseline to Week 48
Measured: Week 48
(Part A) Change in Left Ventricular Mass Index (LVMI) from baseline to Week 48
Measured: Week 48
(Part A) Change in Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) from baseline to Week 48
KCCQ-23 is a patient reported outcome instrument with minimum score = 0 and maximum score = 100 where higher score indicates better health status. There are no units to the score.
Measured: Week 48
(Part B) Change in AVC score as assessed by non-contrast CT from baseline to Week 48
Measured: Week 48
(Part B) Time to decision to proceed with TAVR/SAVR or all-cause death
Measured: Week 158
(Part B) Percentage of participants with progression to AVA <1.0cm2 at Week 48
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start27 Jun 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kardigan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001800
- Sponsor's protocol ID
- ATA-301
- Acronym
- KATALYST-AV
- Status last verified
- May 2026
- First submitted
- 13 May 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksoy O, Tintut Y, Demer LL. Lipids and lipoproteins in calcific aortic valve disease. Curr Opin Lipidol. 2026 Aug 13. doi: 10.1097/MOL.0000000000001053. Online ahead of print.
PubMed 42592935
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07001800
- Acronym / sponsor ID
- KATALYST-AV / ATA-301
- Conditions
- Moderate Aortic Valve Stenosis
- Keywords
- Ataciguat, sGC activator, sGC stimulator, Aortic valve stenosis, Moderate aortic valve stenosis, Calcific aortic valve stenosis, CAVS, Moderate Calcific Aortic Valve Stenosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,276 participants (estimated)
- Lead sponsor
- Kardigan, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
Detailed description
This study will be conducted in two parts: Part A and Part B. The purpose of Part A is to investigate whether ataciguat slows the progression of aortic valve calcium (AVC) deposition in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. Approximately 132 participants will be enrolled in Part A. Enrollment in Part B will begin once enrollment in Part A is complete. The purpose of Part B is to investigate whether ataciguat slows the rate of aortic valve area (AVA) loss and to evaluate the effect of ataciguat on peak oxygen consumption (VO2) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated. Approximately 1144 participants will be enrolled in Part B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ataciguat | Experimental | Drug: Ataciguat |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male or female at least 50 years of age
- Has moderate CAVS as defined by:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtaciguatAtaciguat will be administrated daily for up to 156 weeks | Drug | Ataciguat |
| PlaceboPlacebo will be administrated daily for up to 156 weeks | Drug | Placebo |
Primary outcome
(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24
Time frame: Week 24
(Part B Dual-Primary) Percent change in Aortic Valve Area (AVA) as measured by echocardiogram from baseline to Week 48
Time frame: Week 48
(Part B Dual-Primary) Change in peak VO2 by CPET from baseline to Week 48
Time frame: Week 48
8 secondary outcomes
(Part A) Correlation in the change in AVC as assessed by non-contrast CT and change in VO2 at Week 48
Time frame: Week 48
(Part A) Change in VO2 from baseline to Week 48
Time frame: Week 48
Change in left ventricular diastolic function as assessed by E/e' from baseline to Week 48
Time frame: Week 48
(Part A) Change in Left Ventricular Mass Index (LVMI) from baseline to Week 48
Time frame: Week 48
(Part A) Change in Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) from baseline to Week 48
Time frame: Week 48
(Part B) Change in AVC score as assessed by non-contrast CT from baseline to Week 48
Time frame: Week 48
(Part B) Time to decision to proceed with TAVR/SAVR or all-cause death
Time frame: Week 158
(Part B) Percentage of participants with progression to AVA <1.0cm2 at Week 48
Time frame: Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 42592935Aksoy O, Tintut Y, Demer LL. Lipids and lipoproteins in calcific aortic valve disease. Curr Opin Lipidol. 2026 Aug 13. doi: 10.1097/MOL.0000000000001053. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
74 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ataciguat in people with Moderate Aortic Valve Stenosis, run by Kardigan, Inc. at 74 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kardigan Clinical Trial Information Team (1-877-310-5135, clinicaltrials@kardigan.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24 (time frame: Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.