Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT05020704
Eligibility Criteria:
Inclusion Criteria:
* • Male or female ≥18 years of age
* Informed consent
* Diagnosis of a type 1 acute myocardial infarction meeting the Fourth Universal Definition of Myocardial Infarction (STEMI or NSTEMI)
* Left ventricular ejection fraction \<45% (changed from ≤40% by an amendment to the trial protocol on 23/Feb/2023) as measured by cardiac MRI performed ≥12 hours and ≤14 days following hospital admission with an acute type 1 myocardial infarction). For patients with an in-hospital myocardial infarction as qualifying event, randomization must still occur within 14 days of hospital admission.
* eGFR ≥30 ml/min/1.73m2 at the time of randomisation (calculated using the CKD-EPI formula)
Exclusion Criteria:
* Inability to give informed consent e.g. due to significant cognitive impairment.
* Diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) prior to admission with acute myocardial infarction.
* Systolic blood pressure \<90 mmHg at randomisation.
* Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation.
* Coronary Artery Bypass Grafting (CABG) planned at time of randomisation.
* Type II acute myocardial infarction
* Any current severe (stenotic) valvular heart disease.
* Diagnosis of Takotsubo cardiomyopathy
* Type I diabetes mellitus.
* History of ketoacidosis.
* Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device.
* Permanent or persistent atrial fibrillation.
* Enrollment in another randomised clinical trial involving medical or device-based interventions (co-enrolment in observational studies is permitted)
* Currently pregnant, planning pregnancy, or currently breastfeeding
* History of allergy to SGLT2i.
* Current or planned use of an SGLT2i at time of randomisation.
* Active genital tract infections.
* Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons.
* Contra-indication to contrast-enhanced cardiac MRI i.e. claustrophobia, metallic foreign object unsuitable for MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05020704
Study Brief:
Protocol Section:
NCT05020704