Effect of Dapagliflozin on LV Remodeling Post AMI

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    60
  • sponsor
    Instituto Mexicano del Seguro Social
Updated on 16 March 2021

Summary

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

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.

Details
Condition Myocardial Infarction, Heart Attack (Myocardial Infarction), Ischemic Heart Disease, Cardiac Ischemia, Myocardial Ischemia, Heart Attack (Myocardial Infarction), Cardiac Ischemia, Myocardial Ischemia, heart attack, myocardial infarction (mi), cardiac infarction, heart attacks, myocardial necrosis
Treatment Placebo, Dapagliflozin
Clinical Study IdentifierNCT04783870
SponsorInstituto Mexicano del Seguro Social
Last Modified on16 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Acute myocardial infarction treated within the 24 hours of beginning of symptoms
Signed informed consent
SBP > 90 mmHg
Age >= 18 years

Exclusion Criteria

Glomerular Filtration Rate < 30 ml/min/1.73 m2
Pregnant or lactating woman
Cancer or life-threatening condition
Use of continuous parental inotropic agents
Psychiatric disease incompatible with being in study
Any contraindication to MRI procedures
Any other medical or physical condition considered to be inappropriate by a study physician
Scheduled for a PCI or CABG within the next 6 months
Hemodynamic unstability
Currently on any SGLT2i
One or more episodes of severe hypoglicemia
Acute urinary or genital infection
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