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NCT05618223
Dapagliflozin Effect on Rheumatic Mitral Stenosis
Conditions: Rheumatic Heart Disease, Heart Failure, Mitral Stenosis
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE3
Enrollment: 36
Sponsor: Universitas Sebelas Maret
Location: Indonesia
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.
Eligibility Criteria
Inclusion Criteria:Severe mitral stenosis by echocardiographic examination of the planimetric method with morphology that supports the etiology of rheumaticHeart failure in functional class II-IIIDapagliflozin naiveException Criteria:Other significant valve diseasesPregnant or breastfeedingUnstable hemodynamic conditions including cardiogenic shockhistory of mitral valve replacement/repair or mitral balloon valvuloplastyhistory of hypoglycemiaeGFR below 25 mmHgdiffuse pulmonary fibrosis
Source: ClinicalTrials.gov (NCT05618223). StuddyBuddy aggregates publicly available trial information.