NCT05875675

Effects of Pioglitazone in Calcific Aortic Valve Disease

Effect of Pioglitazone Treatment in Patient's Calcific Aortic Valve Disease With Mild Aortic Valve Stenosis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Calcification of Aortic Valve
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DRUG	Drug: Pioglitazone Oral Tablet	Dietary Supplement: Pioglitazone 30 mg by mouth daily
DIETARY_SUPPLEMENT	Placebo	Dietary: Supplement: Placebo

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-07-01
• Completion: 2028-07-01
• First posted: 2023-05-25
• Last updated: 2023-05-25

Regulatory

• FDA-regulated drug study