Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction

Phase 4Not Yet RecruitingNCT07621380

Shanghai Zhongshan Hospital476 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

476

Conditions

Type 2 Diabetes Mellitus Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults aged 19 years or older 2. Clinically confirmed type 2 diabetes mellitus (T2DM) 3. First acute myocardial infarction (AMI) with planned randomization within 72 hours of AMI onset 4. Ability to understand and voluntarily sign written informed consent Exclusion Criteria: 1. Type 1 diabetes mellitus or history of diabetic ketoacidosis 2. Gestational diabetes, pregnancy, or breastfeeding 3. End-stage renal disease (ESRD), dialysis, or prior kidney transplantation 4. Use of any SGLT2 inhibitor within 4 weeks prior to enrollment 5. Hemodynamic instability or investigator judgment that participation is not in the patient's best interest 6. Systolic blood pressure \< 90 mmHg at enrollment or requiring vasopressors to maintain blood pressure

Outcomes

Primary Outcomes

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