[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599949":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":30,"responsibleParty":40,"collaborators":30,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":30,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":30,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":30,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":30},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"manidipine 10 mg","EXPERIMENTAL","Participants are giving manidipine 10 mg once daily for 12 months, followed by a 3-month safety observation.",[13],"Drug: manidipine",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","Participants are giving placebo once daily for 12 months, followed by a 3-month safety observation.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"manidipine 20 mg","Participants are giving manidipine 20 mg once daily for 12 months, followed by a 3-month safety observation.",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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",[9,21],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Placebo",[15],[35],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},"Fei Li","CONTACT","+8615972969897","lifei_union@hust.edu.cn",{"type":41,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100599949","phase-2-exploration-of-manidipine-to-reverse-aortic-valve-calcification-100599949",false,"NCT07091136","Exploration of Manidipine to Reverse Aortic Valve Calcification","Exploration of Manidipine to Reverse Aortic Valve Calcification by Activating Valvular Osteoclasts in Patients With Severe Calcific Aortic Valvular Disease","Inclusion Criteria:\n\n* Male or female adult ≥ 60 years of age at the time of rescruiting.\n* 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\n* Subject provides written informed consent prior to initiation of any study procedures.\n* Subject understands and agrees to comply with planned study procedures.\n\nExclusion Criteria:\n\n* Subject has concomitant moderate or severe mitral or tricuspid valve disease.\n* Subject has left ventricular ejection fraction \\\u003C 50%.\n* Subject previous history of aortic valve surgery, pancreatitis, malignant tumor, drug or alcohol abuse.\n* Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2.5 times the upper limit of normal range.\n* Subjects who cannot undergo Cardiac CT.\n* Pregnant or lactating women.\n* Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment.","ALL","60 Years","85 Years",{"count":53,"type":54},100,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","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.",[60],"Calcific Aortic Valve Disease",[27,62],"Calcific Aortic Valve disease","NOT_YET_RECRUITING","2025-07-21",{"date":66,"type":67},"2025-07-29","ACTUAL",{"date":69,"type":54},"2025-08-01",{"date":71,"type":54},"2026-10-31",{"name":5,"class":6}]