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

January 31, 2024 updated by: Abdallah Heshmat, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiographic changes due to intervention
Time Frame: 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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

April 17, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dapagliflozin and ST2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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