UnknownPhase 3

Dapagliflozin Effect on Rheumatic Mitral Stenosis

Indonesia36 participantsStarted 2022-12-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Improvements of Biomolecular Parameters

Timeframe: 4 weeks

Improvements of Clinical Parameters

Timeframe: 4 weeks

Improvements of Echocardiography Parameters

Timeframe: 4 weeks

Trial details

NCT IDNCT05618223

SponsorUniversitas Sebelas Maret

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-31

Contact for this trial

An Aldia Asrial, MD

+6281229663174 aaldiaa8@gmail.com

View on ClinicalTrials.gov More Rheumatic Heart Disease trials