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Baseline demographics of the Valsartan Heart Failure Trial. Val-HeFT Investigators
J N Cohn1, G Tognoni, R Glazer
1University of Minnesota Medical School, Box 508, 420 Delaware Street S.E., Minneapolis, MN 55455, USA. cohnx001@tc.umn.edu
Insights
The Valsartan Heart Failure Trial (Val-HeFT) evaluated valsartan in heart failure patients. Results showed the study population is representative of mild to moderate heart failure patients in industrialized nations.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- The Valsartan Heart Failure Trial (Val-HeFT) is a landmark multinational study.
- It investigates valsartan, an angiotensin II receptor blocker, as an add-on therapy for heart failure.
- The study includes patients with ejection fraction <40% receiving conventional treatment.
Purpose of the Study:
- To present and compare baseline characteristics of Val-HeFT participants.
- To establish the representativeness of the Val-HeFT cohort.
Main Methods:
- Randomized, multinational clinical study design.
- Data collection and calculation of summary statistics for baseline characteristics.
- Comparison of baseline data with other major heart failure trials.
Main Results:
- The study population (n=5010) has a mean age of 62.7 years, 80% male, and 90.3% white.
- Common comorbidities include coronary heart disease (57.2%).
- High rates of conventional therapy use: ACE inhibitors (92.7%), diuretics (85.8%), digoxin (67.3%), and beta-blockers (35.6%).
Conclusions:
- The Val-HeFT population is broadly representative of patients with mild to moderate heart failure in industrialized countries.
- Baseline characteristics showed minimal variation across subgroups (age, sex, race, ejection fraction).
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.