Baseline Demographics of the Valsartan Heart Failure Trial

BACKGROUND: The Valsartan Heart Failure Trial (Val-HeFT) is the first large-scale randomized, multinational clinical study to assess the efficacy and safety of valsartan, an angiotensin II receptor blocker, added to conventional therapy, including angiotensin-converting enzyme inhibitors, in heart failure patients. A total of 5010 patients with an ejection fraction <40% have been randomized to either valsartan titrated to 160 mg b.i.d. or to placebo. AIMS: Baseline characteristics of patients in Val-HeFT are presented and compared with other major clinical trials in heart failure. METHODS: Baseline data were collected and summary statistics calculated. RESULTS: The study population has a mean age of 62.7 years and is 80% male, 90.3% white, 6.9% black, and 2.8% Asian. Antecedent coronary heart disease is reported in 57.2% of patients. Angiotensin-converting enzyme inhibitors are prescribed for 92.7% of patients, diuretics for 85.8%, digoxin for 67.3%, and beta-blockers for 35.6%. Subgroup comparisons by age, sex, race and ejection fraction quartile show small differences in baseline characteristics. CONCLUSION: Overall the Val-HeFT population is generally representative of the population of patients with mild to moderate heart failure in industrialized countries.