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

Sponsor

Omar Younis (Other)

Overall Status

Completed

CT.gov ID

NCT05424315

Collaborator

Ain Shams University (Other)

100

Enrollment

Locations

Arms

6.9

Actual Duration (Months)

Patients Per Site

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior MI	Drug: Dapagliflozin 10mg Drug: Glucose Tab	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Group Participants will receive Dapagliflozin 10mg once daily.	Drug: Dapagliflozin 10mg 10mg Tab once daily
Placebo Comparator: Control Group Participants will receive a glucose tab once daily.	Drug: Glucose Tab Placebo Oral Tablet

Arm

Intervention/Treatment

Active Comparator: Intervention Group

Participants will receive Dapagliflozin 10mg once daily.

Drug: Dapagliflozin 10mg

10mg Tab once daily

Placebo Comparator: Control Group

Participants will receive a glucose tab once daily.

Drug: Glucose Tab

Placebo Oral Tablet

Outcome Measures

Primary Outcome Measures

A change in NT-proBNP levels from baseline to 12 weeks post-anterior STEMI [12 weeks]
Difference between both groups in the change of NT-proBNP levels from baseline to 12 weeks post-anterior STEMI
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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.