NCT07621380Not yet recruitingPhase 4
Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction
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
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 476 (estimated)
- First submitted
- 27 May 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07621380
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 476
- From 1 Jul 2026 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- End-stage renal disease (ESRD), dialysis, or prior kidney transplantation
- Use of any SGLT2 inhibitor within 4 weeks prior to enrollment
Other illness
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Gestational diabetes, pregnancy, or breastfeeding
Other
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.