The Effect of Early Administration of Dapagliflozin in STEMI Patients With LV Systolic Dysfunction

STEMI - ST Elevation Myocardial Infarction Clinical Trial

Official title:

The Effect of Early Administration of Dapagliflozin in ST Elevation Myocardial Infarction Patients Presenting With Left Ventricular Systolic Dysfunction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05045274
• Other study ID #: GAgban
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Left Ventricular Systolic Dysfunction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction
• Systolic Murmurs
• Ventricular Dysfunction, Left

Intervention

Drug:
• Dapagliflozin 10Mg Tab
Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI. 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. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 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.
• Placebo
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. Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition. 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic parameter	The improvement in the LVEF (= 5%) using biplane simpson method echocardiography	3 month follow up
Secondary	Changes in LV remodeling	using echocardiography	3 month follow up
Secondary	Changes in diastolic function	using mitral Inflow Patterns electrocardiography	3 month follow up
Secondary	Changes in LA volume index	using by the biplane area-length method from apical 4- and 2-chamber views electrocardiography	3 month follow up
Secondary	Changes in LV mass index.	using by linear method electrocardiography	3 month follow up
Secondary	Laboratory investigations.	Changes of the NT-proBNP from baseline to 3 month follow up	3 month follow up
Secondary	CV death and rehospitalization of HF	Composite of CV death and rehospitalization of HF	3 month follow up
Secondary	Individual component at composite end points.	Composite of CV death or rehospitalization of HF	3 month follow up
Secondary	ACS	Reinfarction or readmission for ACS and target lesion revascularization.	3 month follow up