Dapagliflozin Effect on Rheumatic Mitral Stenosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dapagliflozin Effect on Rheumatic Mitral Stenosis

Conditions
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Rheumatic Heart Disease, Heart Failure, Mitral Stenosis

Intervention / Treatment
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* Drug: Dapagliflozin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pre and post-test design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin group<br>Dapagliflozin 10 mg once a day and standard treatment | Drug: Dapagliflozin<br>* Dapagliflozin 10 mg once daily in addition to standard therapy<br>|
| No Intervention: Control group<br>Standard treatment only. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events | All cause cardiac rehospitalization | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatic heart disease, mitral stenosis, heart failure