Left Ventricular Systolic Dysfunction, STEMI - ST Elevation Myocardial Infarction
Conditions
Brief summary
300 STIMI patients with LV systolic dysfunction will be divided into two equal groups (Group I (Study arm, n=150); will receive dapagliflozin plus conventional therapy and group (II) Control arm (n=150); will receive conventional therapy only to detect an improvement in the LVEF by ≥ 5
Detailed description
300 STIMI patients with LV systolic dysfunction will be randomly divided into two equal groups (Group I (Study arm, n=150); will receive 1. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis. 2. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 3. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload. 4. Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI. Group (II) Control arm (n=150); will receive 1. Reperfusion therapy: as in study arm 2. Anti-ischemic treatment: as in study arm. 3. Anti-failure treatment: as in study arm. LV echocardiographic analysis for both groups at baseline and 3 month follow up by 2D Echocardiography to assess: LVEF by simpson method Diastolic function LV diameter and volume. LA volume index. LV mass index. Severity of MR. Laboratory investigation substudy analysis: 50 patients from either group will undergo NT-proBNP at baseline and after 3 month follow up. Clinical outcomes: Patients will be followed up in a deducted outpatient clinic for assessment of clinical outcomes either by phone cell or clinic visits at 3 month. Patients will be assessed for the following clinical parameters: I. Composite of CV death and rehospitalization of HF. II. Individual component at composite end points. III. Reinfarction or readmission for ACS and target lesion revascularization. Research outcome measures: a. Primary (main): 1\. The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography. a. Secondary (subsidiary): 1. Echocardiographic parameters at 3 month follow up. 1. Changes in LV remodeling. 2. Changes in diastolic function 3. Changes in LA volume index. 4. Changes in LV mass index. 2. Laboratory investigations. Changes of the NT-proBNP from baseline to 3 month follow up 3. Clinical outcomes at 3month. I. Composite of CV death and rehospitalization of HF. II. Individual component at composite end points. III. Reinfarction or readmission for ACS and target lesion revascularization.
Interventions
DRUGDapagliflozin 10Mg Tab
1. Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI. 2. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis. 3. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 4. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
DRUGPlacebo
1. Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis. 2. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 3. Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1st time STEMI within 24 hours undergoing PPCI. (Chest pain \> 30 minutes and ST segment elevation in more than one lead, include the definition of MI with a reference: Third universal definition of MI. (published at ESC Clinical Practice Guidelines 2012). * LVEF less than 50%. * eGFR ≥20 mL/min/1.73 m2.
Exclusion criteria
* Patients less than 18 years old. * T1D (Type I diabetes mellitus). * Hemodynamically unstable. * Cardiogenic shock (clinical syndrome of tissue hypoperfusion resulting from cardiac dysfunction). * History of chronic symptomatic HF with a prior hHF within last year * Patients on dialysis. * Serious hypersensitivity to dapagliflozin (eg, anaphylaxis, angioedema). * Pregnant or lactating women. * Sever hepatic impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic parameter | 3 month follow up | The improvement in the LVEF (≥ 5%) using biplane simpson method echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in diastolic function | 3 month follow up | using mitral Inflow Patterns electrocardiography |
| Changes in LA volume index | 3 month follow up | using by the biplane area-length method from apical 4- and 2-chamber views electrocardiography |
| Changes in LV mass index. | 3 month follow up | using by linear method electrocardiography |
| Changes in LV remodeling | 3 month follow up | using echocardiography |
| CV death and rehospitalization of HF | 3 month follow up | Composite of CV death and rehospitalization of HF |
| Individual component at composite end points. | 3 month follow up | Composite of CV death or rehospitalization of HF |
| ACS | 3 month follow up | Reinfarction or readmission for ACS and target lesion revascularization. |
| Laboratory investigations. | 3 month follow up | Changes of the NT-proBNP from baseline to 3 month follow up |
Outcome results
None listed