NCT06619600

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The DAPA-STEMI trial is a clinical research study designed to investigate whether dapagliflozin, a medication known as a sodium-glucose cotransporter 2 inhibitor (SGLT2i), can reduce the extent of heart muscle damage and improve heart function in patients who have experienced a heart attack. Specifically, the study focuses on patients who have had a type of heart attack known as a ST-segment elevation myocardial infarction (STEMI), which is a serious condition that often leads to long-term heart damage and heart failure. The study aims to answer whether treatment with dapagliflozin can reduce the amount of scarring (fibrosis) that develops in the heart after a heart attack, and whether this reduction in scarring improves the overall function of the heart. Scarring in the heart can lead to stiffening of the heart muscle, which affects its ability to pump blood effectively and can result in heart failure. By using advanced imaging techniques, such as cardiac magnetic resonance imaging (MRI), the study will measure changes in the heart\'s structure and function over time. The primary question the study seeks to answer is whether dapagliflozin can decrease the amount of heart muscle scarring (fibrosis) and improve heart function when compared to a placebo (an inactive treatment). The study will also examine whether dapagliflozin affects other important heart health markers, such as blood levels of proteins that indicate heart muscle damage and the overall size and function of the heart chambers. The study will enroll patients aged 30 to 85 who have recently experienced a STEMI and undergone successful treatment to open the blocked artery. Participants will be randomly assigned to receive either dapagliflozin or a placebo for six months, and their heart function and scarring will be monitored through imaging and blood tests during that time. The results of this study may provide important insights into new ways to protect the heart after a heart attack and prevent the development of heart failure, offering potential benefits to a wide range of patients who experience heart attacks.

Conditions

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

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin 10 mg qd
DRUG	Placebo	Matched placebo qd

Timeline

• Start date: 2021-05-30
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2024-10-01
• Last updated: 2025-02-19

Locations

2 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study