Dapagliflozin Effect on Rheumatic Mitral Stenosis

Sponsor
Universitas Sebelas Maret
Study ID
NCT05618223
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg once daily in addition to standard therapy

Study Details

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.

Key Dates

Start date
Dec 1, 2022
Status verified
Nov 2022
Primary completion
May 31, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin group
    Dapagliflozin 10 mg once a day and standard treatment
  • No Intervention: Control group
    Standard treatment only.

Primary Outcome Measure

Improvements of Biomolecular Parameters [ Time Frame: 4 weeks ]

Central Contacts

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