Dapa-Rhemis: Dapagliflozin Effect on Rheumatic Mitral Stenosis

Sponsor

Universitas Sebelas Maret (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05618223

Collaborator

(none)

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatic Heart Disease Heart Failure Mitral Stenosis	Drug: Dapagliflozin	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Pre and post-test designPre and post-test design

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dapagliflozin Effect on Rheumatic Mitral Stenosis

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dapagliflozin group Dapagliflozin 10 mg once a day and standard treatment	Drug: Dapagliflozin Dapagliflozin 10 mg once daily in addition to standard therapy
No Intervention: Control group Standard treatment only.

Arm

Intervention/Treatment

Experimental: Dapagliflozin group

Dapagliflozin 10 mg once a day and standard treatment

Drug: Dapagliflozin

Dapagliflozin 10 mg once daily in addition to standard therapy

No Intervention: Control group

Standard treatment only.

Outcome Measures

Primary Outcome Measures

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 Clinical Parameters [4 weeks]
Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition)
Improvements of Echocardiography Parameters [4 weeks]
Net atrioventricular compliance in mL/mmHG, mitral valve gradient in mmHg and mPAP in mmHg

Secondary Outcome Measures

Major Adverse Cardiac Events [4 weeks]
All cause cardiac rehospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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