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

NCT05335629 | Completed

• 1 other identifier: Dapagliflozin and ST2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Dapagliflozin; ST2; Myocardial infarction; Cardiac remodeling; T2DM

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Echocardiographic changes due to intervention

  4 weeks

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

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

Control arm

NO INTERVENTION

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

Interventions

Dapagliflozin 10Mg Tab DRUG

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

Intervention arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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
• AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN
• CrCl \< 60 ml/min (based on the Cockroft-Gault equation)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospitals

Cairo, Egypt

Location

Related Publications (26)

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MeSH Terms

Conditions

Myocardial Infarction; Diabetes Mellitus, Type 2; Ventricular Remodeling

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacy demonstrator

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 19, 2022
• Study Start: June 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)