100
Participants
Start Date
August 1, 2025
Primary Completion Date
August 1, 2026
Study Completion Date
October 31, 2026
manidipine
study will enrol 100 adults aged 60 to 85 years with MDCT-confirmed mild-to-moderate aortic valve calcification (Agatston score 300-2 000 AU) and preserved left-ventricular ejection fraction to receive manidipine 10 mg, manidipine 20 mg, or matched placebo once daily for 12 months, followed by a 3-month safety observation, with the primary endpoint being the absolute and relative change in aortic valve calcium score at 12 months; secondary endpoints include echocardiographic valve area and transvalvular gradients, six-minute walk distance, peak oxygen uptake, and comprehensive safety outcomes
Placebo
study will enrol 100 adults aged 60 to 85 years with MDCT-confirmed mild-to-moderate aortic valve calcification (Agatston score 300-2 000 AU) and preserved left-ventricular ejection fraction to receive manidipine 10 mg, manidipine 20 mg, or matched placebo once daily for 12 months, followed by a 3-month safety observation, with the primary endpoint being the absolute and relative change in aortic valve calcium score at 12 months; secondary endpoints include echocardiographic valve area and transvalvular gradients, six-minute walk distance, peak oxygen uptake, and comprehensive safety outcomes
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER