Telmisartan in Haemodialysis Patients With Chronic Heart Failure

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second University of Naples; University of Campania "Luigi Vanvitelli"
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors; Telmisartan

Criteria

Inclusion Criteria:

• Adult haemodialysis patients with CHF;

• New York Heart Association (NYHA) class II and III;

• Ejection fraction less or equal to 40% determined within 6 months; and

• Therapy with ACE inhibitors individually optimized and unchanged for 30 days before randomization

Exclusion Criteria:

• Hypotension during dialysis;

• Atrial fibrillation;

• Intolerant to low dose of telmisartan