Could a heart pill delay valve replacement?

NCT ID NCT07715279

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 238 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

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

35 to 80 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

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