DACAMIImpact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients - DACAMI (a Randomized Controlled Clinical Trial)
Dapagliflozin 10mg
+ Glucose Tab
Enfermedades Cardiovasculares+7
+ Enfermedades del Corazón
+ Insuficiencia Cardíaca
Estudio de Prevención
Resumen
Fecha de inicio: 1 de octubre de 2021
Fecha en la que se inscribió al primer participante.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).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 100 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
Cardiology Department, Faculty of Medicine, Ain Shams University
Cairo, EgyptAbrir Cardiology Department, Faculty of Medicine, Ain Shams University en Google MapsNational Heart Institute
Cairo, Egypt