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

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 0 to 1v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07621380
Lead Sponsor Shanghai Zhongshan Hospital
Conditions
(from sponsor)		 Type 2 Diabetes Mellitus Myocardial Infarction
Enrollment 476 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov