Effect of Dapagliflozin on LV Remodeling Post AMI

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783870
• Other study ID #: F-2020-3604-035
• Status: Recruiting
• Phase: Phase 4
• Start date: March 3, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2021
• Source: Instituto Mexicano del Seguro Social
• Contact: Eduardo Almeida-Gutierrez, MD
• Phone: +52 5556276900
• Email: eduardo.almeida[@]imss.gob.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Dapagliflozin
Dapagliflozin 10 mg PO QD
• Placebo
Placebo

Locations

Country	Name	City	State
Mexico	Hospital de Cardiología, Centro Médico Nacional Siglo XXI	Ciudad de México

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular remodeling	Changes in end-diastolic and end-systolic left ventricular volumes	6 months
Secondary	Natriuretic peptides	Change in natriuretic peptide	6 months
Secondary	Quality of life assessed with KCCQ	Change in quality of life	6 months