NCT05618223

Dapagliflozin Effect on Rheumatic Mitral Stenosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Universitas Sebelas Maret · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Rheumatic mitral stenosis remains a health problem in developing countries. Progressive fibrosis of the valves and myocardium is the main pathophysiology that plays an important role. Dapagliflozin has various beneficial effects on the heart by reducing fibrosis, reducing inflammation, and improving patient quality of life. However, the role of this therapy is unknown in patients with rheumatic mitral stenosis.

Detailed description

This study is an open-label study on Rheumatic Mitral Stenosis patients, carried out at Sebelas Maret University Hospital Sukoharjo, Panti Rahayu Hospital Purwodadi, and Permata Bunda Hospital Purwodadi. Researchers divided 36 Rheumatic Mitral Stenosis patients sequentially into two groups, the first was the dapagliflozin group which would receive dapagliflozin 10 mg once a day and standard treatment. And the second group will only get standard treatment. Each patient will be examined on PICP, MMP-1, MMP-1/TIMP-1 ratio, TGF-β, Net atrioventricular compliance index, NT-pro BNP, and Kansas City Cardiomyopathy Questionnaire on day 1 and one month after the intervention.

Conditions

• Rheumatic Heart Disease
• Heart Failure
• Mitral Stenosis

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin 10 mg once daily in addition to standard therapy

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-05-31
• Completion: 2023-06-30
• First posted: 2022-11-16
• Last updated: 2022-11-21

Locations

1 site across 1 country: Indonesia