Clinical trial NCT05045274: The Effect of Early Administration of Dapagliflozin in STEMI Patients With LV Systolic Dysfunction
Official title: The Effect of Early Administration of Dapagliflozin in ST Elevation Myocardial Infarction Patients Presenting With Left Ventricular Systolic Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: STEMI - ST Elevation Myocardial Infarction
Left Ventricular Systolic Dysfunction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Echocardiographic parameter
timeFrame: 3 month follow up
Secondary outcomes:
measure: Changes in LV remodeling
timeFrame: 3 month follow up
measure: Changes in diastolic function
timeFrame: 3 month follow up
measure: Changes in LA volume index
timeFrame: 3 month follow up
measure: Changes in LV mass index.
timeFrame: 3 month follow up
measure: Laboratory investigations.
timeFrame: 3 month follow up
measure: CV death and rehospitalization of HF
timeFrame: 3 month follow up
measure: Individual component at composite end points.
timeFrame: 3 month follow up
measure: ACS
timeFrame: 3 month follow up
Other outcomes:
Locations:
Study officials:
References: