Short and Intermediate Term Effect of Dapagliflozin on Left Ventricular Remodeling in Anterior STEMI Patients

NCT05957887 | Recruiting Phase 3 FDA Drug

• 1 other identifier: Cardio1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Methodology This study will enroll (120) patients presenting with acute anterior STEMI who will undergo early reperfusion presenting at Helwan University Hospitals and Ain Shams University Hospitals. Diagnosis of STEMI will be based on: Sustained ST-segment elevation of at least 1 mm in at least 2 contiguous leads or new/presumably new left bundle branch block, plus \>Typical anginal pain, or \> diagnostic levels of serum cardiac biomarkers, or \> imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. They will be subdivided into two (2) groups according to Dapagliflozin intake into: \- Group A: Patients with diabetes mellitus (DM) (60) patients, they will be further subdivided into 2 subgroups: Group A1: 30 patients will receive Dapagliflozin in addition to standard anti-ischemic and anti-diabetic treatment. Group A2: 30 patients will receive standard anti-ischemic and antidiabetic treatment (Dapagliflozin not included). \- Group B: Patients without DM (60) patients, subdivided to 2 subgroups: Group B1: 30 patients will receive standard anti-ischemic treatment. Group B2: 30 patients will receiv up e standard anti-ischemic treatment and Dapagliflozin. Methodology in details: The study patients will undergo early reperfusion according to the recent practice guidelines and the local hospital policy in managing ST elevation MI patients. Echocardiography will be performed twice: within 48 hours of admission and 3 months following the index event. Management: Twelve-lead electrocardiogram will be recorded at baseline and 30-min post-procedure. The ST-segment changes will be evaluated in the single lead with the most prominent ST-segment elevation before intervention. The ST-segment elevation will be measured to the nearest 0.5 mm at 60 ms after the J point. Significant ST segment resolution (STR) is defined as a reduction in ST-segment elevation of 50% after 30 min of infarct artery recanalization. Immediately before the procedure, patients will receive aspirin (300 mg), ticagrelor (180 mg) or clopidogrel (600 mg) depending on availability. Adjunctive pharmacological treatment during the procedure will include:

1. 1.Unfractionated heparin as an initial bolus of 70 U/kg and additional boluses during the procedure to achieve an activated clotting time of 250 to 350 s (200 to 250 s if Glycoprotein IIb/IIIa (GPIIb/IIIa) antagonist is used). Heparin will be discontinued at the end of percutaneous coronary intervention.
2. 2.The use of a GPIIb/IIIa antagonist during the procedure, primary PCI technique, indications, and methods of thrombectomy if indicated will be done under the regulations of the local hospital policy and the most recent practice guidelines.

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

• number of patients with acute ST elevation anterior myocardial infarction who took Dapagliflozin who shows improvement in cardiac remodeling (assessed by 2D echocardiogram (by measuring GLS)

  GLS is global longitudinal strain which is measured by 2D echocardiogram (normal GLS \> -20) the absolute value of GLS is decreased in impaired LV systolic function

  18 months

Secondary Outcomes (1)

• Assess of cardiac toxicity in patients presented with acute ST elevation anterior myocardial infarction

  18 months

Study Arms (4)

Dapagliflozin use in diabetic patients with anterior STEMI

ACTIVE COMPARATOR

Drug: Dapagliflozin

diabetic patients with anterior STEMI without Dapagliflozin

NO INTERVENTION

Dapagliflozin use in non-diabetic patients with anterior STEMI

ACTIVE COMPARATOR

Drug: Dapagliflozin

Non-diabetic patients with anterior STEMI without Dapagliflozin

NO INTERVENTION

Interventions

Dapagliflozin DRUG

Assess the efficacy of Dapagliflozin on cardiac function and LV remodeling in acute ST elevation anterior myocardial infarction patients

Dapagliflozin use in diabetic patients with anterior STEMI; Dapagliflozin use in non-diabetic patients with anterior STEMI

Eligibility Criteria

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

You may qualify if:

• STEMI with time from symptom onset of \<48 hours duration.
• Capable of giving signed informed consent.

You may not qualify if:

• Patients with a history of old myocardial infarction.
• Patients with a history of previous coronary artery bypass surgery (CABG).
• Hemodynamically unstable patients.
• Patients with suboptimal echocardiographic images
• Patients with any cardiac rhythm other than sinus rhythm.
• Unsuccessful angiographic reperfusion (Thrombolysis In Myocardial Infarction \[TIMI\] flow grade \<2).
• Patients with renal dysfunction. (GFR\<30mmol/L).
• Patients who have recently undergone immunosuppressive therapy.
• Patients with a history of recurrent urinary tract infections.
• Patients who are known to be allergic to SGLT-2 inhibitors.
• Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
• Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
• Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitors).

Sponsors & Collaborators

• Mohamed Nabil Elkholy: lead

Study Sites (1)

Helwan University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Mohamed Nabil, Msc

CONTACT

01026276274; m_n_k_1987@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist, Cardiology Department, Principle Investigator

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: July 24, 2023
• Study Start: April 15, 2022
• Primary Completion: March 15, 2025
• Study Completion: April 15, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

EG (1)