Using dapagliflozin to reduce heart damage in STEMI patients

The University of Ottawa Dapagliflozin in STEMI Randomized Clinical Trial

This study is testing if the medication dapagliflozin can help reduce heart damage in patients who have just had a heart attack and are receiving treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Heart Institute Research Corporation (Academic / other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT06174753 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of dapagliflozin, an SGLT2 inhibitor, in minimizing heart damage in patients experiencing ST Elevation Myocardial Infarction (STEMI) who are undergoing primary percutaneous coronary intervention (PPCI). Eligible participants will be randomly assigned to receive either dapagliflozin or a placebo for seven days. Cardiovascular Magnetic Resonance (CMR) imaging will be utilized to measure the size of the heart infarct at days 3-5, with follow-up visits scheduled at 30, 90, and 180 days to monitor cardiovascular events.

Who should consider this trial

Good fit: Ideal candidates are adults experiencing STEMI with specific high-risk ECG criteria who are referred for PPCI.

Not a fit: Patients under 18 years old, those with contraindications to CMR imaging, or those with certain medical conditions such as type 1 diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce heart damage in patients suffering from STEMI, potentially improving recovery outcomes.

How similar studies have performed: Previous studies have shown promising results with SGLT2 inhibitors in cardiovascular contexts, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

Patients referred for PPCI meeting the following criteria are eligible for the study:

* Ischemic chest discomfort of ≥30 minutes duration, and
* Onset of chest pain ≤12 hours prior to entry into the study, and
* One of the following High-Risk criteria on a standard 12 lead ECG:

  a. Anterior STEMI with ST-segment elevation ≥2mm (0.2 mV) in each of at least 2 contiguous precordial leads (V1-V6) b. Extensive non-anterior STEMI defined as ST-segment elevation of \>1mm in two or more contiguous non-anterior leads accompanied by i. 8 or more leads with \> 1 mm ST elevation or depression, or both; OR ii. Sum of ST- segment elevation \>20mm

Exclusion Criteria:

* Age \< 18 years
* Any contraindication to undergo CMR imaging
* Killip 4 (Cardiogenic shock on presentation)
* Therapy with SGLT2i within last 8 weeks
* Type 1 diabetes mellitus
* Pregnancy
* Nursing mother
* Unwilling to use appropriate forms of contraception, as applicable
* Chronic symptomatic HF with prior hospitalization for HF within the last year
* hospitalization
* Known history of prior MI
* Any non-CV condition with a life expectancy of less than one year
* Previous randomization in the present study
* Participation in a study with another investigational device or drug \< four weeks
* Inability to provide informed consent
* Confirmed ketoacidosis at time of admission
* Known severe hepatic impairment (Cirrhosis)
* Severe renal impairment (eGFR \< 30 mL/min1.73m2 (based on prior or baseline blood work)
* Known severe valvular heart disease
* Need for CABG within 90 days based on the results of the initial coronary angiogram
* False positive STEMI (based on the results of the coronary angiogram)

Where this trial is running

Ottawa, Ontario

• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Michel LeMay, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Poppy MacPhee, BScN

Conditions ST Elevation Myocardial Infarction; Myocardial Infarction