Dapagliflozin Effect on Rheumatic Mitral Stenosis

Phase 3

Not yet recruiting

• Conditions: Rheumatic Heart Disease; Heart Failure; Mitral Stenosis
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT05618223
• Lead Sponsor: Universitas Sebelas Maret

Brief 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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-16
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-21
• Study Start: 2022-12-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin group	Dapagliflozin	Dapagliflozin 10 mg once a day and standard treatment

Primary Outcome Measures

Name	Time	Method
Improvements of Clinical Parameters	4 weeks	Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition)
Improvements of Biomolecular Parameters	4 weeks	PICP in pg/ml, MMP-1 in pg/ml, MMP-1/TIMP-1 ratio, TGF-β in pg/ml, NT-ProBNP in pg/ml
Improvements of Echocardiography Parameters	4 weeks	Net atrioventricular compliance in mL/mmHG, mitral valve gradient in mmHg and mPAP in mmHg

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	4 weeks	All cause cardiac rehospitalization

Trial Locations

Locations (1)

Sebelas Maret University Hospital; 🇮🇩 Sukoharjo, Central Java, Indonesia