Could a heart pill delay valve replacement?
NCT ID NCT07715279
First seen Jul 20, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study tests whether the drug vericiguat can slow the buildup of calcium on the aortic valve in people with mild-to-moderate aortic valve stenosis. Participants take vericiguat or a placebo daily for 24 months, with regular heart scans to track valve calcium and function. The goal is to see if the drug can delay the need for valve replacement surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vericiguat, an oral soluble guanylate cyclase stimulator
- What this could lead to
- If it works, this could lead to the first drug therapy to slow aortic valve disease, potentially delaying or avoiding the need for valve replacement surgery.
- What could go wrong
- This is a Phase 2 trial with 238 participants, so results are preliminary. The drug may not slow disease progression, and side effects like low blood pressure are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 238 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The participant agrees to enter this clinical trial and consents to long-term follow-up; 2. 35 ≤ age \< 80 years; 3. Echocardiographically confirmed mild-to-moderate (peak aortic jet velocity ≥ 2.5 m/s and \< 4.0 m/s, aortic valve area \> 1.0 cm², and mean aortic valve pressure gradient \< 40 mmHg) non-rheumatic aortic valve stenosis; 4. Baseline aortic valve calcium score (Agatston score) ≥ 200 AU as measured by cardiac CT; 5. Male participants, or female participants who are not of childbearing potential, or female participants who commit to avoiding pregnancy through 4 weeks after the end of the trial. Exclusion Criteria: 1. Severe aortic stenosis (AS peak velocity ≥ 4.0 m/s, or mean transvalvular aortic pressure gradient ≥ 40 mmHg, or aortic valve area ≤ 1.0 cm², or indexed effective aortic valve area \< 0.6 cm²/m²), or very mild stenosis (AS peak velocity \< 2.5 m/s), or a planned aortic valvuloplasty/replacement procedure; 2. Concomitant severe mitral or tricuspid valve disease (moderate or greater mitral or tricuspid regurgitation, or prior mitral or tricuspid valve repair/valvuloplasty/replacement); 3. Concomitant moderate or greater aortic regurgitation; 4. Use, within 1 month prior to the screening visit, of medications affecting the NO-sGC-cGMP pathway (e.g., sildenafil, nitrates, etc.), or known hypersensitivity to vericiguat or its components; 5. Left ventricular ejection fraction (LVEF) \< 50%, or NYHA class III-IV (see Appendix 4 for NYHA classification criteria); 6. Presence of a malignancy (except those with an expected cure) or other serious non-cardiac disease with a life expectancy of less than 3 years; 7. Rheumatic valvular heart disease; 8. Systolic blood pressure (SBP) \< 120 mmHg, or a history of symptomatic hypotension, or a history of hemodynamic instability or hypovolemia within the 4 weeks prior to screening; 9. Presence of hypertrophic obstructive cardiomyopathy (outflow tract obstruction defined as a peak left ventricular outflow tract pressure gradient ≥ 30 mmHg at rest or after provocative testing); 10. Infective endocarditis or complex congenital heart disease; 11. Estimated glomerular filtration rate \< 15 mL/min/1.73 m², or on dialysis; 12. Severe pulmonary disease requiring continuous home oxygen therapy; 13. Interstitial lung disease; 14. Concomitant disorder of calcium-phosphate metabolism; 15. Current use of warfarin; 16. ALT and AST ≥ 3 times the upper limit of normal, or severe hepatic insufficiency (e.g., cirrhosis, chronic active liver disease); 17. Inability to undergo contrast-enhanced CT, or contrast media allergy; 18. Concomitant acute myocarditis, cardiac amyloidosis, cardiac sarcoidosis, or stress (takotsubo) cardiomyopathy; 19. Presence of acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction) within 60 days prior to randomization, or an indication for coronary revascularization (percutaneous intervention/bypass surgery); or a need for coronary revascularization identified at the time of randomization; 20. History of cerebrovascular accident (including TIA or stroke) within 60 days prior to randomization; 21. Psychiatric disorder or legal incapacity precluding the ability to provide informed consent; 22. Any medical condition, circumstance, or history that, in the investigator's judgment, would compromise the participant's ability to participate in or complete the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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