Effects of Dapagliflozin on Heart Function in Patients with Anterior STEMI

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

This study is testing if adding the diabetes medication Dapagliflozin to standard treatment can improve heart function in patients who have had an acute heart attack.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Helwan University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT05957887 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the short and intermediate-term effects of Dapagliflozin on left ventricular remodeling in patients with acute anterior STEMI. A total of 120 patients will be enrolled, with those having diabetes mellitus divided into two groups: one receiving Dapagliflozin alongside standard treatment and the other receiving standard treatment alone. The study will assess the impact of Dapagliflozin on heart function following early reperfusion therapy. The trial is conducted at Helwan University Hospitals and Ain Shams University Hospitals.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with acute anterior STEMI within 48 hours of symptom onset, particularly those with diabetes mellitus.

Not a fit: Patients with a history of old myocardial infarction, severe renal dysfunction, or those who are hemodynamically unstable may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve heart function and outcomes for patients recovering from anterior STEMI.

How similar studies have performed: Previous studies have shown promising results with SGLT-2 inhibitors in heart failure and myocardial infarction, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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.
* Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
* 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).

Where this trial is running

Cairo

• Helwan University — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Mohamed Nabil, Msc

Conditions STEMI