© 2000 European Society of Cardiology
Baseline demographics of the Valsartan Heart Failure Trial
a University of Minnesota Medical School Box 508, 420 Delaware Street S.E., Minneapolis, MN 55455, USA
b Mario Negri Institute Milan, Italy
c Novartis Pharmaceuticals Corporation East Hanover, NJ, USA
d Novartis Pharma AG Basel, Switzerland
* Corresponding author. Tel.: +1-612-625-5646; fax: +1-612-624-2174. E-mail addresscohnx001{at}tc.umn.edu (J.N. Cohn).
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Abstract |
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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 β-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.
Key Words: Heart failure • Clinical trial • Baseline demographics • Angiotensin receptor blocker • Valsartan
Accepted October 4, 2000
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