Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05335629

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective, randomized, controlled study will be conducted at Clinical Cardioglogy department, Ain Shams University Hospitals, assessing the efficacy and tolerability of SGLT2 inhibitors (dapagliflozin) addition on the clinical outcome and cardiac remodeling markers of post myocardial infarction (MI) diabetic patients

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Diabetes Mellitus, Type 2 Myocardial Remodeling, Ventricular	Drug: Dapagliflozin 10Mg Tab	N/A

Detailed Description

All patients presenting to the Clinical Cardiology department, Ain Shams University

Hospitals, will be assessed for eligibility as follow:

Inclusion criteria:

Female or male aged >18 and < 75 years
Diabetic post myocardial infarction patients
First anterior STEMI with successful TIMI-3 flow
STEMI within 12 hrs of onset of chest pain
creatine clearance ≥60 mL/min
HbA1c between 6.5% and 12.0%

Exclusion criteria:

Cardiogenic shock on admission
Multivessel disease on admission
Mechanical complications e.g. mitral regurge on admission
Life threatening arrhythmia on admission
Hemodynamic instability on admission
Diagnosis of Type 1 diabetes mellitus
History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
Pregnant or breast-feeding patients
Active participation in another clinical study
AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
CrCl < 60 ml/min (based on the Cockroft-Gault equation)

Eligible patients will be randomly assigned into one of 2 arms:

Group 1 (Healthy control) (n=10) Aged-matched healthy volunteers who do not suffer any diseases.
Group 2 (Control group) (n= 30): Post-MI patients who will receive standard of care for 4 Weeks
Group 3 (Test group) (n= 30): Post-MI patients who will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks

Dapagliflozin will be administered immediately at time of PCI and daily for 4 weeks.
Standard of care will given to both arms (group 2 and 3) and includes:

Dual Antiplatelet Therapy (DAPT), high intensity statin, anticoagulation therapy, ACEI or aldosterone antagonist depending on the ejection fraction

All subjects will sign an informed consent statement prior to inclusion in the study.
All subjects will be followed up for 4 weeks and blood samples will be withdrawn at baseline, 1 week, and the end of the study to test for ST2 (suppression of tumerogenicity 2) biomarker

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Evaluation of the Effect of Dapagliflozin on Cardiac Remodeling in Post Myocardial Infarction Patients

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention arm 30 patients will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks Interventions: Drug: Dapagliflozin 10 mg oral tablets Standard of care: Dual antiplatelet therapy, Statin, anticoagulation therapy	Drug: Dapagliflozin 10Mg Tab Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor) which is a new class of hypoglycemic drugs, and they can block sodium-dependent glucose transporter-2 (SGLT2) located in the early proximal renal tubule to increase urinary glucose excretion and decrease the concentration of blood glucose
No Intervention: Control arm 30 patients will receive standard of care (Dual antiplatelet therapy, Statin, anticoagulation therapy) for 4 weeks

Arm

Intervention/Treatment

Active Comparator: Intervention arm

30 patients will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks Interventions: Drug: Dapagliflozin 10 mg oral tablets Standard of care: Dual antiplatelet therapy, Statin, anticoagulation therapy

Drug: Dapagliflozin 10Mg Tab

Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor) which is a new class of hypoglycemic drugs, and they can block sodium-dependent glucose transporter-2 (SGLT2) located in the early proximal renal tubule to increase urinary glucose excretion and decrease the concentration of blood glucose

No Intervention: Control arm

30 patients will receive standard of care (Dual antiplatelet therapy, Statin, anticoagulation therapy) for 4 weeks

Outcome Measures

Primary Outcome Measures

Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction [4 weeks]
patients will be followed up for the whole period of the study and blood sample will be drawn at baseline and at study end to track changes in the level of ST2 (suppression of tumerogenicity 2) which is a cardiac remodeling biomarker using ELISA technique

Secondary Outcome Measures

Echocardiographic changes due to intervention [4 weeks]
patients will have their echocardiography and ejection fraction will be compared at baseline and at the end of the study to track any changes that may be caused by intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Female or male aged >18 and < 75 years
Diabetic post myocardial infarction patients
First anterior STEMI with successful TIMI-3 flow
STEMI within 12 hrs of onset of chest pain
creatine clearance ≥60 mL/min
HbA1c between 6.5% and 12.0%

Exclusion Criteria:

Cardiogenic shock on admission
Multivessel disease on admission
Mechanical complications e.g. mitral regurge on admission
Life threatening arrhythmia on admission
Hemodynamic instability on admission
Diagnosis of Type 1 diabetes mellitus
History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
Pregnant or breast-feeding patients
Active participation in another clinical study
AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
CrCl < 60 ml/min (based on the Cockroft-Gault equation)