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Question In hemodialysis patients with chronic heart failure (CHF) and impaired left ventricular ejection fraction (LVEF), does adding telmisartan to standard therapies reduce mortality and morbidity? Methods Design Randomized placebo-controlled trial. ClinicalTrials.gov NCT00490958. Allocation Concealed.* Blinding Blinded (patients and clinicians).* Follow-up period Mean 35.5 months. Setting 30 clinics of a dialysis provider network in Italy. Patients 332 adults (mean age 63 y, 54% men) who were receiving hemodialysis and had CHF (New York Heart Association functional class II or III), had LVEF >40% within 6 months, and were receiving individually optimized and unchanged angiotensin-converting enzyme (ACE) inhibitors for >30 days before randomization. Intervention Telmisartan, titrated to a target dose of 80 mg/d (n =>165), or placebo (n =>167). Outcomes Primary outcomes were all-cause mortality, cardiovascular death, and hospitalization for worsening CHF. Secondary outcomes included acute nonfatal myocardial infarction (MI) and nonfatal stroke. Patient follow-up 86% (intention-to-treat analysis). Main results Patients in the telmisartan group had lower rates of all-cause mortality, cardiovascular death, and hospitalization for CHF than did the placebo group; groups did not differ for nonfatal MI or stroke (Table). Conclusion In hemodialysis patients with chronic heart failure (CHF) and impaired left-ventricular ejection fraction, adding telmisartan to standard therapy with angiotensin-converting enzyme inhibitors reduced all-cause and cardiovascular mortality and hospitalizations for CHF. [ABSTRACT FROM AUTHOR] |
