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NCT Number: NCT05424315

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cardiology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients with Diabetes Miletus (Type 1 (DMT2), Type 1 (DMT1), secondary diabetes (e.g., endocrinopathies)
  • Patients already diagnosed with heart failure prior to this event
  • Patients on cardiotoxic chemotherapeutic medications.
  • Patients with haemoglobinopathies.
  • Patients with chronic organ damage (i.e., chronic hepatitis with MELD score >10, Stage 4 & 5 renal disease).
  • Patients already on SGLT2i.
  • Patients who will require additional anticoagulant therapy (i.e.: patients with transthoracic echocardiographic evidence of left ventricular thrombus).
  • 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.

Treatment and study plan

Dapagliflozin 10mg

Drug

10mg Tab once daily

Other names: PubChem CID 9887712, BMS-512148, (1S)-1,5-anhydro-1-C-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}--glucitol, Forxiga, Edistride

Glucose Tab

Drug

Placebo Oral Tablet

Other names: PubChem CID 5793, D-Glucose, D-Glc

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Omar Younis

Other Gov

Collaborators

  • Ain Shams University

Registry information

Official study title

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

Acronym: DACAMI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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