Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients (DACAMI)

March 23, 2024 updated by: Omar Younis

Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients - DACAMI (a Randomized Controlled Clinical Trial)

Sodium glucose co-transporter 2 inhibitors (SGLT2i) proved their favorable outcomes in heart failure. However, it is still unknown if their role extent into preventing heart failure, especially after acute myocardial infarction. This study aimed at identifying if there is such role for SGLT2i.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A notable breakthrough in the management of heart failure is the use of a class of anti-diabetic medications known as, gliflozins. Gliflozins act by inhibiting the sodium glucose co-transporter 2 (SGLT-2). This is a transmembrane protein found at the luminal border of tubular cells of the proximal convoluted tubules of the kidney. It accounts for around 90% of glucose re-absorption. Inhibiting the SGLT-2 results in better glycemic control in patient with diabetes mellitus type 2 (DMT2).

In heart failure, sodium glucose co-transporter 2 inhibitors (SGLT2i - i.e., gliflozins) were found to have a favorable cardiovascular outcome independent of their anti-glycemic effect. In patients with acute myocardial infarction, the heart function as a pump is affected & heart failure develops. In particular, patients with anterior ST-elevation myocardial infarction (STEMI) are at a higher risk of remodeling & heart failure. This is due to the cutoff in blood supply in the left anterior descending (LAD) coronary artery which supplies a great area of left ventricle.

A question that rises: is there a role for SGLT2i, & in particular dapagliflozin, in acute myocardial infarction in improving post-infarction cardiac function & preventing heart failure? especially in patients who experience Anterior ST-Elevation Myocardial Infarction (STEMI).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cardiology Department, Faculty of Medicine, Ain Shams University
      • Cairo, Egypt
        • National Heart Institute

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

Description

Inclusion Criteria:

  • Patients admitted with ECG Criteria for Anterior ST-elevation myocardial infarction according to the fourth universal definition of myocardial infarction*, ** & show echocardiographic evidence of reduced LV ejection fraction <50% & have undergone successful reperfusion by primary percutaneous coronary angiography (pPCI).

    • New ST segment elevation in contagious precordial leads consistent anatomically with the anterior wall of myocardium:

      • Men ≥ 40 years: 2 mV in leads V2-V3 &/or 1 mV in other precordial leads
      • Men <40 years: 2.5 mV in leads V2-V3 &/or 1 mV in other precordial leads
      • Women (regardless of age): 1.5 mV in leads V2-V3 &/or 1 mV in other precordial leads ** Patients with admission ECG showing DeWinter's Syndrome, Wellen Syndrome, New onset left bundle branch block, new onset right bundle branch block will also be included.

Exclusion Criteria:

  1. Patients with Diabetes Miletus (Type 1 (DMT2), Type 1 (DMT1), secondary diabetes (e.g., endocrinopathies)
  2. Patients already diagnosed with heart failure prior to this event
  3. Patients on cardiotoxic chemotherapeutic medications.
  4. Patients with haemoglobinopathies.
  5. Patients with chronic organ damage (i.e., chronic hepatitis with MELD score >10, Stage 4 & 5 renal disease).
  6. Patients already on SGLT2i.
  7. Patients who will require additional anticoagulant therapy (i.e.: patients with transthoracic echocardiographic evidence of left ventricular thrombus).
  8. Patients with contraindications for use of dapagliflozin including patients with severely impaired renal function (eGFR <30ml/min/1.73m2) &/OR previous history of genitourinary infections (i.e.: urosepsis, pyelonephritis & fournier's gangrene) &/OR at high risk of such infections.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group
Participants will receive Dapagliflozin 10mg once daily.
Drug: Dapagliflozin 10mg
10mg Tab once daily
Other Names:
  • Forxiga
  • BMS-512148
  • PubChem CID 9887712
  • (1S)-1,5-anhydro-1-C-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}--glucitol
  • Edistride
Placebo Comparator: Control Group
Participants will receive a glucose tab once daily.
Drug: Glucose Tab
Placebo Oral Tablet
Other Names:
  • PubChem CID 5793
  • D-Glucose
  • D-Glc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change in NT-proBNP levels from baseline to 12 weeks post-anterior STEMI
Time Frame: 12 weeks
Difference between both groups in the change of NT-proBNP levels from baseline to 12 weeks post-anterior STEMI
12 weeks
A change in left ventricular ejection fraction, end-diastolic volume or left ventricular mass index assessed by transthoracic echocardiography at baseline, 4 weeks & 12 weeks post-anterior STEMI
Time Frame: 12 weeks
Difference between both groups in the change of the above mentioned echocardiographic parameters assessed at baseline, 4 weeks & 12 weeks post-anterior STEMI
12 weeks

Collaborators and Investigators

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

Sponsor

Omar Younis

Collaborators

Ain Shams University

Investigators

  • Principal Investigator: Khairy Abdul-Dayem, M.D., Cardiology Department, Faculty of Medicine, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTN1012021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available through a data repository link provided to the publishing journal.

Shared Data will include baseline characteristics of the intervention and control group. Moreover, NT-proBNP and Echocardiographic outcomes will be available.

IPD Sharing Time Frame

Access to the data will be feasible once the results are published.

IPD Sharing Access Criteria

Access to the data will be feasible once the results are published after a formal request to the investigators. Approval of the the investigators is a must.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • 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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