Effect of Dapagliflozin on LV Remodeling Post AMI

Instituto Mexicano del Seguro Social

Status and phase: Enrolling; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04783870

F-2020-3604-035

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Dapagliflozin

Experimental group

Description:

Dapagliflozin 10 mg PO QD

Treatment:

Drug: Dapagliflozin

Control

Placebo Comparator group

Description:

Placebo PO QD

Treatment:

Drug: Placebo