Clinical trial NCT05335629: Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients
Official title: Evaluation of the Effect of Dapagliflozin on Cardiac Remodeling in Post Myocardial Infarction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Diabetes Mellitus, Type 2
Myocardial Remodeling, Ventricular
Keywords: Dapagliflozin
ST2
Myocardial infarction
Cardiac remodeling
T2DM
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction
timeFrame: 4 weeks
Secondary outcomes:
measure: Echocardiographic changes due to intervention
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospitals
Study officials:
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