Effect of Dapagliflozin on LV Remodeling Post AMI

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

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

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Placebo; Drug: Dapagliflozin

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eduardo Almeida-Gutierrez, MD; Phone Number: 22007 +52 5556276900; Email: eduardo.almeida@imss.gob.mx

Study Locations

• Mexico
  • Ciudad de México, Mexico, 06720
    • Recruiting
    • Hospital de Cardiología, Centro Médico Nacional Siglo XXI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dapagliflozin; Dapagliflozin 10 mg PO QD	Drug: Dapagliflozin; Dapagliflozin 10 mg PO QD
PLACEBO_COMPARATOR: Control; Placebo PO QD	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular remodeling	Changes in end-diastolic and end-systolic left ventricular volumes	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natriuretic peptides	Change in natriuretic peptide	6 months
Quality of life assessed with KCCQ	Change in quality of life	6 months

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Investigators: Principal Investigator: Juan B Ivey-Miranda, MD, Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: F-2020-3604-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared only to researches with extensive research. These will be analyzed on case-by-case basis.
• IPD Sharing Time Frame: After the study termination
• IPD Sharing Access Criteria: IPD will be shared only to researches with extensive research. These will be analyzed on case-by-case basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No