The non-insulin-dependent diabetes, hypertension, microalbuminuria or proteinuria, cardiovascular events, and Ramipril (DIABHYCAR) study: Design, organization, and patient recruitment

The non-insulin-dependent DIABetes, HYpertension, microalbuminuria or prote inuria, CARdiovascular events, and Ramipril (DIABHYCAR) study is a randomiz ed, prospective, double-blind, placebo-controlled, multicenter internationa l trial of the ACE inhibitor ramipril (1.25 mg/day) in patients with type I I diabetes and micro- or macroalbuminuria. The main outcome of the study is the time to first occurrence of either death from a cardiovascular origin, including sudden death, nonfatal myocardial infarction, stroke, or congest ive heart failure, or requirement of hemodialysis or renal transplantation. The study was launched in France in early 1995 with the participation of g eneral practitioners only, but had to be extended to 15 other countries in 1997 due to difficulties in recruitment. Since 2.5 years after the beginnin g of the trial the observed event rate was much less than anticipated, it w as decided to increase recruitment and follow-up duration and to include co ngestive heart failure in the definition of the main outcome to keep the st udy power at a satisfactory level. Recruitment ended on April 1, 1998 with 4937 randomized patients. Following the early discontinuation for efficacy of another study of ramipril in high cardiovascular risk patients, the Hear t Outcomes Prevention Evaluation study (HOPE), the second interim analysis of DIABHYCAR was performed early (when 406 instead of 500 patients presente d a main outcome) and the Data Safety and Monitoring Board recommended that the study continue. Follow-up is planned to end on March 31, 2001. (C) Els evier Science Inc. 2000.