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Clinical Trials/NCT05335629
NCT05335629
Completed
Not Applicable

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

Ain Shams University1 site in 1 country54 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Dapagliflozin 10Mg Tab
Conditions
Myocardial Infarction
Sponsor
Ain Shams University
Enrollment
54
Locations
1
Primary Endpoint
Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
October 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdallah Heshmat

Clinical pharmacy demonstrator

Ain Shams University

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Dapagliflozin 10Mg Tab

Outcomes

Primary Outcomes

Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction

Time Frame: 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 Outcomes

  • Echocardiographic changes due to intervention(4 weeks)

Study Sites (1)

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