Effect of Pioglitazone Treatment in Patient's Calcific Aortic Valve Disease With Mild Aortic Valve Stenosis
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- overall survival
Study Overview
Brief Summary
This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of pioglitazone compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.
Detailed Description
Pioglitazone is an oral drug for the treatment of type 2 diabetes that improves the utilization of glucose by the body by inhibiting hepatic gluconeogenesis, and has anti-inflammatory and antioxidant effects that may improve vascular endothelial cell injury and prevent cardiovascular disease. This study is to slow the process of aortic valve calcification by pioglitazone intervention with the aim of reducing the risk of aortic valve stenosis. Participants were randomized into two groups: one group was given oral pioglitazone treatment and the other group was given placebo control. Patients in both groups were observed for aortic valve calcification during the follow-up period, and changes in aortic valve thickness, degree of calcification, and flow were recorded by cardiac ultrasonography, while the incidence of cardiovascular events and adverse effects were assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female adult ≥ 35 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.
Arms & Interventions
Control group
Dietary Supplement: Placebo
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
overall survival
Time Frame: 3 years
overall survival (OS)
Secondary Outcomes
- Change in aortic valve stenosis severity(at week 104)
- Glucose level(104 weeks)
- Time-to-major adverse cardiovascular events(104 weeks)
- HbA1c(104 weeks)