© 2005 European Society of Cardiology
Signs and symptoms in chronic heart failure: Relevance of clinical trial results to point of care—data from Val-HeFT
a VA Greater Los Angeles Healthcare System and the David Geffen School of Medicine at UCLA Los Angeles, United States
b Istituto di Ricerche Farmacologiche Mario Negri Milan, Italy
c Novartis Pharmaceuticals Corporation East Hanover, NJ, United States
d University of Minnesota Minneapolis, MN, United States
* Corresponding author. 1661 Pine Street, #819 San Francisco, CA 94109, United States. Tel.: +1 415 447 5467. E-mail address: maylene617{at}yahoo.com
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Abstract |
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Background: Clinical trials emphasize mortality and morbidity endpoints.
Aims: To bring relevance of trial results to point of care by examining the prognostic and therapeutic value of individual signs and symptoms (S&S).
Methods: We analysed data from 5010 patients with stable chronic heart failure and left ventricular dysfunction who were participants in the Val-HeFT study. Individual S&S were stratified by severity. Treatment differences between valsartan and placebo were analysed by S&S strata at baseline and endpoint by logistical regression, and an overall S&S score by ANCOVA. Hazard ratios of S&S strata were calculated for mortality and heart failure hospitalisation. Prognostic contributions of S&S to other variables were determined by multivariate analysis.
Results: At endpoint, there were significantly fewer valsartan and more placebo patients with severe symptoms. Over time, improvement in the S&S overall score was significantly more favourable for valsartan than placebo. S&S strata were significantly predictive of risk for hospitalisation and death. S&S were each independent and incremental predictors of mortality compared to other variables. Symptom strata separated out moderately symptomatic patients with a mortality rate which was intermediate between that for NYHA Class II and III.
Conclusion: Risk stratification of individual S&S defined prognosis, identified patients with an intermediate mortality between Class II and III, and treatment benefits of valsartan over placebo.
Key Words: Orthopnoea • Resting and paroxysmal nocturnal dyspnoea
Received June 1, 2005; Revised August 26, 2005; Accepted November 1, 2005
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