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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Myocardial Remodeling, Ventricular; Myocardial Infarction
• Interventions: Drug: Dapagliflozin 10Mg Tab

• Registration Number: NCT05335629
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-19
• Study Start: 2022-06-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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%

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Dapagliflozin 10Mg Tab	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ain shams university hospitals; 🇪🇬 Cairo, Egypt