Zhongshan Hospital, Fudan University
Shanghai, China
Location contact
Daile Jia, MD
SUB_INVESTIGATOR
Junbo Ge, MD
CONTACT
Junbo Ge, MD
PRINCIPAL_INVESTIGATOR
Not Yet Recruiting
NCT Number: NCT07621380
Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
19 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Ertugliflozin 10 mg
DrugErtugliflozin 10mg, oral, once daily
Standard AMI Care
OtherStandard pharmacotherapy for acute myocardial infarction without Ertugliflozin
Primary outcomes
-
Percent change in NT-proBNP from baseline
Time frame: 26 weeks
Percent change in serum NT-proBNP levels from baseline to week 26, assessed by mixed-effects model for repeated measures (MMRM)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shanghai Zhongshan Hospital
Other
Registry information
Official study 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
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jun 2, 2026
- Registry last updated
- Jun 24, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.