Dapagliflozin Effect on Rheumatic Mitral Stenosis

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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 increasing fibrosis, reducing inflammation, and improving patients' quality of life. However, the role of this therapy is unknown in patients with rheumatic mitral stenosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitas Sebelas Maret
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Severe mitral stenosis by echocardiographic examination of the planimetric method with morphology that supports the etiology of rheumatic

• Heart failure in functional class II-III

• Dapagliflozin naive

Exception Criteria:

• Other significant valve diseases

• Pregnant or breastfeeding

• Unstable hemodynamic conditions including cardiogenic shock

• history of mitral valve replacement/repair or mitral balloon valvuloplasty

• history of hypoglycemia

• eGFR below 25 mmHg

• diffuse pulmonary fibrosis