Heart Failure, Mitral Stenosis, Rheumatic Heart Disease
Conditions
Keywords
rheumatic heart disease, mitral stenosis, heart failure
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.
Interventions
DRUGDapagliflozin
Dapagliflozin 10 mg once daily in addition to standard therapy
Sponsors
Universitas Sebelas Maret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pre and post-test design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events | 4 weeks | All cause cardiac rehospitalization |
Countries
Indonesia
Contacts
Primary ContactAn Aldia Asrial, MD
Backup ContactAnggit Pudjiastuti, MD
Outcome results
None listed