FOSIDIAL: a randomised placebo controlled trial of the effects of fosinopril on cardiovascular morbidity and mortality in haemodialysis patients. Study design and patients' baseline characteristics

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Abstract
The prevalence of end stage renal disease (ESRD) is growing in western countries. Patients with ESRD are more frequently elderly and diabetic and are exposed to very high cardiovascular morbidity and mortality. The main aim of the FOSIDIAL study is to assess the efficacy and safety of fosinopril, an angiotensin converting enzyme (ACE) inhibitor, in reducing the mortality and cardiovascular events in haemodialysis patients presenting with left ventricular hypertrophy. A total number of 397 patients are included in the study. They are aged 50–80 years (average 66.7 years) and have been undergoing haemodialysis for 4.8 years. All have left ventricular hypertrophy with cardiac mass index > 100 g/m2 in women and > 130 g/m2 in men, measured within 3 months prior to inclusion. Baseline cardiac mass index is 174 g/m2. After a 2 week placebo period, the patients are randomised into two groups receiving either fosinopril 5–20 mg/day, or a placebo for a duration of 24 months. The target dose is reached at the sixth, seventh or eighth week of treatment. Depending on tolerance, 300 patients reached the maximum recommended dose. Patients are subsequently assessed clinically every 3 months until the end of the study. The primary outcome is a composite endpoint of fatal and nonfatal major cardiovascular events. Secondary endpoints are individual cardiovascular events, event‐free survival, overall mortality and all‐cause hospitalisations. The trial began in October 1998. All patients were included by December 2000 and follow‐up is ongoing. The last visit for the last patient is scheduled for 30 December 2002. We report here on the study design and the baseline characteristics of the study population.