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

Ain Shams University

Status: Completed

Conditions: Myocardial Remodeling, Ventricular; Myocardial Infarction; Diabetes Mellitus, Type 2

Treatments: Drug: Dapagliflozin 10Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05335629

Dapagliflozin and ST2

Details and patient eligibility

About

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

Full description

All patients presenting to the Clinical Cardiology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:

Inclusion criteria:

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

Exclusion criteria:

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

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

1. Group 1 (Healthy control) (n=10) Aged-matched healthy volunteers who do not suffer any diseases.

2. Group 2 (Control group) (n= 30): Post-MI patients who will receive standard of care for 4 Weeks

3. 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

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Intervention arm

Active Comparator group

Description:

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

Treatment:

Drug: Dapagliflozin 10Mg Tab

Control arm

No Intervention group

Description:

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