Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ertugliflozin 10 mg, Standard AMI Care.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus Myocardial Infarction. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Ertugliflozin on NT-proBNP and Cardiac Function After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded Endpoint (PROBE) Trial
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 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.
Interventions
- Drug Ertugliflozin 10 mg
Ertugliflozin 10mg, oral, once daily - Other Standard AMI Care
Standard pharmacotherapy for acute myocardial infarction without Ertugliflozin
Primary outcome measures
- Percent change in NT-proBNP from baseline [Time frame: 26 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Hemodynamic instability or investigator judgment that participation is not in the patient's best interest
- Systolic blood pressure < 90 mmHg at enrollment or requiring vasopressors to maintain blood pressure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT07621380 · B2026-325