Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorShanghai Zhongshan Hospital
About this trial
This prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluates the efficacy of early ertugliflozin initiation (10 mg daily) compared to standard care alone on cardiac function in 476 adult patients with type 2 diabetes mellitus (T2DM) following a first acute myocardial infarction (AMI). The study is supported by scientific rationale suggesting potential effects of ertugliflozin on cardiac resident macrophages in the heart after myocardial infarction.The primary objective is to assess the change in NT-proBNP levels from baseline to 26 weeks, while secondary endpoints explore echocardiographic parameters (such as LVEF and LAVi) and metabolic indices including blood ketone levels, HbA1c, and body weight. Eligible participants are randomized in a 1:1 ratio within 72 hours of AMI onset and followed for a total of 30 weeks to monitor both efficacy outcomes and safety events, with a specific focus on serious adverse events like severe hypoglycemia, genital infections, and ketoacidosis.
Eligibility criteria
Qualifiers
Adults aged 19 years or older
Clinically confirmed type 2 diabetes mellitus (T2DM)
First acute myocardial infarction (AMI) with planned randomization within 72 hours of AMI onset
Ability to understand and voluntarily sign written informed consent
Disqualifiers
Type 1 diabetes mellitus or history of diabetic ketoacidosis
Gestational diabetes, pregnancy, or breastfeeding
End-stage renal disease (ESRD), dialysis, or prior kidney transplantation
Use of any SGLT2 inhibitor within 4 weeks prior to enrollment
Trial design
Treatments tested in this trial
- Ertugliflozin 10 mg
- Standard AMI Care
Treatment groups
476 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov