Valsartan significantly improved the overall signs and symptoms score compared to placebo, and individual symptom strata independently predicted mortality and heart failure hospitalization.
RCT (n=5,010)
Does valsartan improve signs and symptoms compared to placebo, and do these signs and symptoms predict mortality and hospitalization in patients with stable chronic heart failure?
Individual signs and symptoms in chronic heart failure provide independent prognostic value for mortality and hospitalization, and are significantly improved by valsartan compared to placebo.
Abstract 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.
Wong et al. (Thu,) conducted a rct in stable chronic heart failure and left ventricular dysfunction (n=5,010). valsartan vs. placebo was evaluated on overall signs and symptoms score, mortality, and heart failure hospitalisation. Valsartan significantly improved the overall signs and symptoms score compared to placebo, and individual symptom strata independently predicted mortality and heart failure hospitalization.