NCT04783870

Effect of Dapagliflozin on LV Remodeling Post AMI

Effect of Dapagliflozin on Left Ventricular Remodeling in Patients With Acute Myocardial Infarction

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall hypothesis of the study is that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction.

Detailed description

In patients with heart failure, with or without diabetes, SGLT2i have shown to decrease remodeling. However, this has not been tested in patients following an acute myocardial infarction. Acute myocardial infarction is serious condition with increasing incidence across the world. Following treatment, a reasonable amount of patients develop remodeling of the left ventricle, which is associated with worse prognosis. This occurs despite patients are treated with GDMT. Dapagliflozin is an SGLT2i with biological plausibility to decrease left ventricular remodeling following acute myocardial infarction. In the present study, researchers will test the hypothesis that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction (less than 7 days). This will be a randomized, single-blind, placebo controlled trial. The primary endpoint will be the change in end-diastolic and end-systolic left ventricular volumes from baseline to the end of the intervention (6 months). We will include patients with acute myocardial infarction who have been treated with primary PCI.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin 10 mg PO QD
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-03-03
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-03-05
• Last updated: 2021-03-05

Locations

1 site across 1 country: Mexico