Effect of Dapagliflozin on LV Remodeling Post AMI

March 2, 2021 updated by: Eduardo Almeida Gutiérrez, Instituto Mexicano del Seguro Social

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
Changes in end-diastolic and end-systolic left ventricular volumes
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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