Hyperglycemia and its effect after acute myocardial infarction on cardiovascular outcomes in patients with Type 2 diabetes mellitus (HEART2D) - Study design

Objective: Cardiovascular (CV) disease is the major cause of death in patients with diabetes. Up to 4.0% of patients with Type 2 diabetes mellitus (T2DM) who survive an initial myocardial infarction (MI) suffer a recurrent event within 2 years, the majority of which are fatal. One independent risk factor for cardiovascular disease (CVD) may be postprandial blood glucose (PPBG) excursions. The HEART2D study seeks to determine the effect that PPBG control has on cardiovascular outcomes in patients who suffered an MI within the 21 days before study enrollment. Research design and methods: Approximately 1355 patients with T2DM with recent MI will be entered in this multicenter study of about 3.0-year duration. Using infarct severity and peri-infarct treatment as randomization factors, patients will be assigned to one of two insulin treatment strategies: (1) postprandial strategy: premeal insulin lispro with basal insulin at bedtime if needed (NPH insulin), targeting 2-h PPBG <= 7.5 mmol/l or (2) basal strategy: insulin (NPH insulin twice daily or insulin glargine once daily; or premixed human insulin (70% NPH/30% regular; 30/70) twice daily), targeting fasting and premeal blood glucose (BG; <= 6.7 mmol/l). Both groups will aim for a target hemoglobin AlC (AlC) of < 7%. Anticipated results: The anticipated difference in PPBG (similar to 2.0 to 2.5 mM) between strategies is expected to demonstrate a 15% to 18.5% relative risk reduction in CV events for the postprandial strategy. Conclusion: This study may provide practical insights into the clinical management of patients with diabetes who have an increased risk of recurrent CV events and death. (c) 2005 Elsevier Inc. All rights reserved.