Dapagliflozin Effect on Rheumatic Mitral Stenosis (Dapa-Rhemis)

Universitas Sebelas Maret

Status and phase: Not yet enrolling; Phase 3

Conditions: Rheumatic Heart Disease; Heart Failure; Mitral Stenosis

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT05618223

Dapa-Rhemis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Dapagliflozin group

Experimental group

Description:

Dapagliflozin 10 mg once a day and standard treatment

Treatment:

Drug: Dapagliflozin

Control group

No Intervention group

Description:

Standard treatment only.