Exploration of Manidipine to Reverse Aortic Valve Calcification

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60-85
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • manidipine
  • Placebo

Treatment groups

100 Participants
are divided into 3 treatment groups

Locations

This trial has no locations