Effect of Dapagliflozin in Myocardial Fibrosis and Ventricular Function in Patients With a ST-segment Elevation Myocardial Infarction
NCT06619600 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2025-02-19
Summary
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.
Conditions
- ST-segment Elevation Myocardial Infarction (STEMI)
- Diabetes Mellitus
- Heart Failure
- Myocardial Fibrosis
Interventions
- DRUG
-
Dapagliflozin 10 mg qd
- DRUG
-
Matched placebo qd
Sponsors & Collaborators
-
Hospital Clinic of Barcelona
lead OTHER
Principal Investigators
-
Luis Ortega, MD, PhD · Division of Cardiology, University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, USA.
-
Salvatore Brugaletta, MD, PhD · Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-30
- Primary Completion
- 2025-03-31
- Completion
- 2025-03-31
- FDA Drug
- Yes
Countries
- Spain
Study Locations
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