Effect of Dapagliflozin in Myocardial Fibrosis and Ventricular Function in Patients With a ST-segment Elevation Myocardial Infarction

Sponsor
Hospital Clinic of Barcelona
Study ID
NCT06619600
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Diabetes Mellitus
  • Heart Failure
  • Myocardial Fibrosis
  • ST-segment Elevation Myocardial Infarction (STEMI)

Eligibility Criteria

Sex
ALL
Age
30 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg qd
  • Placebo — DRUG
    Matched placebo qd

Study Details

The DAPA-STEMI trial investigates whether dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), reduces heart muscle scarring (fibrosis) and improves heart function after a ST-segment elevation myocardial infarction (STEMI). The trial will use cardiac MRI to measure changes in heart structure and function over six months. Patients aged 30-85 who have had a recent STEMI will receive either dapagliflozin or a placebo. The study aims to provide mechanistic insights into heart failure prevention after heart attacks.

Key Dates

Start date
May 30, 2021
Status verified
Sep 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg qd
  • Placebo Comparator: Placebo
    Matched placebo qd

Primary Outcome Measure

Extracellular volume (ECV, %) [ Time Frame: 6 months ]

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