Exploration of Manidipine to Reverse Aortic Valve Calcification (NCT07091136) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Exploration of Manidipine to Reverse Aortic Valve Calcification
100 participantsStarted 2025-08-01
Plain-language summary
This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of manidipine compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.
Who can participate
Age range60 Years – 85 Years
SexALL
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Inclusion Criteria:
* Male or female adult ≥ 60 years of age at the time of rescruiting.
* Subject has calcific aortic valve disease with mild to moderate aortic valve stenosis as defined by Doppler echocardiography results: Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Area ≥ 1.2 and ≤ 2.0 cm2 on TTE within 2 weeks prior to randomization and Cardiac Compute Tomography (CT) test results: aortic valve calcium score (Agatston score) ≥ 200 AU at baseline cardiac CT within 1 month prior to randomization
* Subject provides written informed consent prior to initiation of any study procedures.
* Subject understands and agrees to comply with planned study procedures.
Exclusion Criteria:
* Subject has concomitant moderate or severe mitral or tricuspid valve disease.
* Subject has left ventricular ejection fraction \< 50%.
* Subject previous history of aortic valve surgery, pancreatitis, malignant tumor, drug or alcohol abuse.
* Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal range.
* Subjects who cannot undergo Cardiac CT.
* Pregnant or lactating women.
* Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment.
What they're measuring
1
aortic valve calcification
Timeframe: 3 month later than stop drug giving
Trial details
NCT IDNCT07091136
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology