💬In plain words
What the trial is, and whether it could suit you
Calcific aortic valve stenosis (CAVS) is a condition in which the aortic valve progressively narrows and stiffens due to calcium deposition, eventually impairing blood flow from the heart to the body. No drug therapy has been proven to slow CAVS progression. Individuals with mild-to-moderate CAVS are managed with periodic monitoring until the stenosis becomes severe, at which point surgical or transcatheter valve replacement is the only treatment option. The goal of this clinical trial is to determine whether vericiguat, an oral soluble guanylate cyclase (sGC) stimulator, can slow the progression of mild-to-moderate CAVS.
The primary questions this study aims to answer are:
Does vericiguat slow the progression of aortic valve calcium accumulation, as measured by the change in aortic valve calcium score from baseline to 24 months, compared to placebo?
The study will compare vericiguat
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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