Ertugliflozin for Heart Function in People With Type 2 Diabetes After a Heart Attack
Tests ertugliflozin on heart function in adults with type 2 diabetes after a heart attack.
Plain-language title generated from the registry record
Registry title: Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 4
Where in China
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Zhongshan Hospital
- Trial code
- NCT07621380
- Record updated
- 24 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: End-stage renal disease (ESRD), dialysis, or prior kidney transplantation; Use of any SGLT2 inhibitor within 4 weeks prior to enrollment; Type 1 diabetes mellitus or history of diabetic ketoacidosis; Gestational diabetes, pregnancy, or breastfeeding; 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.