Background: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high mortality rate but, presently, very little data is available regarding this population. Aim of the study: Aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in haemodialysis patients with CHF and impaired left ventricular ejection fraction (LVEF) when added to standard therapies with ACE inhibitors. Methods: A 3-year randomized, double-blind, placebo-controlled, multicentre trial was performed involving 30 Italian clinics. Haemodialysis patients with CHF (NYHA class II and III; LVEF 40%) were randomized to telmisartan or placebo in addition to ACE inhibitor therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35±5 months. Primary outcomes were all-cause mortality, cardiovascular mortality and CHF hospitalization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
351
Chair of Cardiology Second University of Naples
Naples, Italy
all cause mortality cardiovascular mortality hospitalization for decompensated heart failure
Time frame: 36 months
acute non-fatal myocardial infarction
Time frame: 36 months
combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)
Time frame: 36 months
cardiovascular hospital admission
Time frame: 36 months
nonfatal stroke
Time frame: 36 months
coronary revascularization
Time frame: 36 months
permanent premature treatment withdrawals
Time frame: 36 months
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