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A Study to Investigate Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis (KATALYST-AV)
EU CTIS ID: 2025-522176-86-01
What this study is testing
Part B: To determine whether ataciguat slows the rate of AVA loss Part B: To evaluate the effect of ataciguat on peak VO2
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Adult male or female at least 50 years of age
- 2. Has moderate CAVS as defined by: a) An AVA of ≥1.0 cm2 to ≤1.50 cm2 b) An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 to 2000 AU for men on non-contrast CT
- 3. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the Imaging Core Laboratory
- 4. For participants 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
- 5. Additional criteria as listed in the protocol may apply
You likely can't join if
- 1. Has a prior aortic valve replacement, repair, surgery, or intervention or an anticipated or planned aortic valve replacement in the next 6 months
- 2. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
- 3. Has suspected or known congenital aortic valve disease including bicuspid aortic valve
- 4. Has New York Heart Association (NYHA) Class III or Class IV heart failure symptoms
- 5. Has a primary etiology for heart failure other than aortic valve disease
- 6. Has coronary artery disease or anticipating coronary stenting surgery
See the full eligibility criteria
- 1. Adult male or female at least 50 years of age
- 2. Has moderate CAVS as defined by: a) An AVA of ≥1.0 cm2 to ≤1.50 cm2 b) An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 to 2000 AU for men on non-contrast CT
- 3. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the Imaging Core Laboratory
- 4. For participants 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
- 5. Additional criteria as listed in the protocol may apply
- 1. Has a prior aortic valve replacement, repair, surgery, or intervention or an anticipated or planned aortic valve replacement in the next 6 months
- 2. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
- 3. Has suspected or known congenital aortic valve disease including bicuspid aortic valve
- 4. Has New York Heart Association (NYHA) Class III or Class IV heart failure symptoms
- 5. Has a primary etiology for heart failure other than aortic valve disease
- 6. Has coronary artery disease or anticipating coronary stenting surgery
- 7. Has an average QTcF ≥480 msec at Screening according to the Investigator’s assessment, risk factors for torsades de pointes, such as hypokalemia, a family history of long QT syndrome, or concurrent use of medications that prolong the QT/QTc interval, abnormal electrocardiogram (ECG) results and/or long-standing persistent or permanent atrial fibrillation
- 8. 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 (e.g. pulmonary disease, joint, leg, hip, back conditions that limit physical activity, or other absolute contraindications for CPET)
- 9. Additional criteria as listed in the protocol may apply
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.