Effects of Telmisartan Added to Angiotensin-Converting Enzyme Inhibitors on Mortality and Morbidity in Hemodialysis Patients With Chronic Heart Failure : A Double-Blind, Placebo-Controlled Trial

Objectives The aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in hemodialysis patients with chronic heart failure (CHF) and impaired left ventricular ejection fraction (LVEF) when added to standard therapies with angiotensin-converting enzyme inhibitors. Background In hemodialysis patients, CHF is responsible for a high mortality rate, but presently very few data are available with regard to this population. Methods A 3-year randomized, double-blind, placebo-controlled, multicenter trial was performed involving 30 Italian clinics. Hemodialysis patients with CHF (New York Heart Association functional class II to III; LVEF 40%) were randomized to telmisartan or placebo in addition to angiotensin-converting enzyme inhibitor therapy. A total of 332 patients were enrolled (165 telmisartan, 167 placebo). Drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35.5 8.5 months (median: 36 months; range: 2 to 40 months). Primary outcomes were: 1) all-cause mortality; 2) cardiovascular mortality; and 3) CHF hospital stay. Results At 3 years, telmisartan significantly reduced all-cause mortality (35.1% vs. 54.4%; p 0.001), cardiovascular death (30.3% vs. 43.7%; p 0.001), and hospital admission for CHF (33.9% vs. 55.1%; p 0.0001). With Cox proportional hazards analysis, telmisartan was an independent determinant of all-cause mortality (hazard ratio [HR]: 0.51; 95% confidence interval [CI]: 0.32 to 0.82; p 0.01), cardiovascular mortality (HR: 0.42; 95% CI: 0.38 to 0.61; p 0.0001), and hospital stay for deterioration of heart failure (HR: 0.38; 95% CI: 0.19 to 0.51; p 0.0001). Adverse effects, mainly hypotension, occurred in 16.3% of the telmisartan group versus 10.7% in the placebo group. Conclusions Addition of telmisartan to standard therapies significantly reduces all-cause mortality, cardiovascular death, and heart failure hospital stays in hemodialysis patients with CHF and LVEF 40%. (Effects Of Telmisartan Added To Angiotensin Converting Enzyme Inhibitors On Mortality And Morbidity In Haemodialysed Patients With Chronic Heart Failure: A Double-Blind Placebo-Controlled Trial; NCT00490958). (J Am Coll Cardiol 2010;56:1701‐8) © 2010 by the American College of Cardiology Foundation Up to 64% of patients with end-stage renal disease (ESRD) have evidence of chronic heart failure (CHF). In hemodialysis patients, CHF is responsible for high rates of mortality and morbidity (1). Although the treatment of patients with CHF in the general population (2–9) is wellestablished, few data are presently available on patients with CHF on hemodialysis treatment. In fact, it is generally assumed that the effect and the dosage of a given drug, See page 1709