Effect of Dapagliflozin on LV Remodeling Post AMI

Phase 4

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Drug: Placebo; Drug: Dapagliflozin

• Registration Number: NCT04783870
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief 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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study Start: 2021-03-03
• Study First Posted: 2021-03-05
• Last Update Posted: 2021-03-05
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Placebo PO QD
Dapagliflozin	Dapagliflozin	Dapagliflozin 10 mg PO QD

Primary Outcome Measures

Name	Time	Method
Left ventricular remodeling	6 months	Changes in end-diastolic and end-systolic left ventricular volumes

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed with KCCQ	6 months	Change in quality of life
Natriuretic peptides	6 months	Change in natriuretic peptide

Trial Locations

Locations (1)

Hospital de Cardiología, Centro Médico Nacional Siglo XXI; 🇲🇽 Ciudad de México, Mexico