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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ertugliflozin 10 mg

    Drug

    Ertugliflozin 10mg, oral, once daily

  • Standard AMI Care

    Other intervention

    Standard pharmacotherapy for acute myocardial infarction without Ertugliflozin

Treatment groups

476 Participants
are divided into 2 treatment groups
Group A: ErtugliflozinExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in NT-proBNP from baseline

Percent change in serum NT-proBNP levels from baseline to week 26, assessed by mixed-effects model for repeated measures (MMRM)

Time frame
26 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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