Trial | NCT00490958  Report issue

Title

Telmisartan in Haemodialysis Patients With Chronic Heart Failure
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    351
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 Started
Jan 31
1999
Study Completion
Jun 30
2005
Last Update
Oct 17
2008
Estimate

Drug 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
No Results Posted