Calcific Aortic Valve Stenosis
Conditions
Interventions
Intervention group (vericiguat treatment group):Vericiguat is initiated orally at 2.5 mg once daily (qd). If systolic blood pressure remains >=100 mmHg after two weeks, the dose is increased to 5 mg q
Control group (placebo group):Patients in the control group will receive a placebo identical in appearance to vericiguat. The number of placebo tablets taken will follow a similar dose escalation sche
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
35 Years to 82 Years
Inclusion criteria
Inclusion criteria: 1. The patient provides informed consent to participate in the clinical trial and agrees to long-term follow-up; 2. Male or female patients aged 35 to 82 years with mild to moderate non-rheumatic aortic stenosis; 3. Transthoracic echocardiography (TTE) shows a peak aortic valve velocity between 2.5 and 4.0 m/s; 4. Baseline aortic valve calcification score (Agatston units) measured by cardiac CT is >=200 AU; 5. Patients must be either male, female without childbearing potential, or female of childbearing potential who agrees to use effective contraception and not become pregnant until at least 4 weeks after the end of the study.
Exclusion criteria
Exclusion criteria: 1. Severe aortic stenosis (AS peak velocity >4.0 m/s), very mild aortic stenosis (AS peak velocity = 3 times the upper limit of normal, or severe hepatic impairment; 16. Unable to undergo contrast-enhanced CT or has known contrast agent allergy; 17. Concomitant acute myocarditis, cardiac amyloidosis, cardiac sarcoidosis, or stress cardiomyopathy; 18. Within 60 days prior to randomization: history of acute coronary syndrome or indication for coronary intervention; 19. Within 60 days prior to randomization: history of cerebrovascular events (including TIA or stroke); 20. Mentally or legally incapacitated and unable to provide informed consent; 21. Any medical condition, situation, or history that, in the opinion of the investigator, may impair the participant’s ability to comply with or complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aortic valve calcification score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Aortic valve calcification score ;Peak aortic jet velocity;Peak aortic jet velocity;Aortic valve area (AVA);Aortic valve area (AVA);Incidence of aortic valve replacement;Incidence of aortic valve replacement; | — |
Countries
China
Contacts
Public ContactMao Chen
West China Hospital, Sichuan University
Outcome results
None listed