Telmisartan in Haemodialysis Patients With Chronic Heart Failure

Summary

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.

Timeline

Start

1999-01

Primary completion

—

Completion

2005-06

Outcome

Met primary endpoint

paper at 3 years, telmisartan significantly reduced all-cause mortality (35.1% vs. 54.4%; p < 0.001) PMID 21070920 ↗

paper cardiovascular death (30.3% vs. 43.7%; p < 0.001) PMID 21070920 ↗

paper and hospital admission for CHF (33.9% vs. 55.1%; p < 0.0001). PMID 21070920 ↗

Publications

• Cice G, Di Benedetto A, D'Isa S, D'Andrea A, Marcelli D, Gatti E, Calabro R. 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. J Am Coll Cardiol. 2010 Nov 16;56(21):1701-8. doi: 10.1016/j.jacc.2010.03.105.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telmisartan	Other / unclassified	80 mg	—

Indications