Exploration of Manidipine to Reverse Aortic Valve Calcification

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

August 1, 2026

Study Completion Date

October 31, 2026

Conditions
Calcific Aortic Valve Disease
Interventions
DRUG

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

DRUG

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

All Listed Sponsors
lead

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

NCT07091136 - Exploration of Manidipine to Reverse Aortic Valve Calcification | Biotech Hunter | Biotech Hunter