DACAMIImpact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients - DACAMI (a Randomized Controlled Clinical Trial)
Dapagliflozin 10mg
+ Glucose Tab
Cardiovascular Diseases+9
+ Heart Diseases
+ Heart Failure
Prevention Study
Summary
Study start date: October 1, 2021
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Cardiology Department, Faculty of Medicine, Ain Shams University
Cairo, EgyptOpen Cardiology Department, Faculty of Medicine, Ain Shams University in Google MapsNational Heart Institute
Cairo, Egypt