Telmisartan in Haemodialysis Patients With Chronic Heart Failure

University of Campania "Luigi Vanvitelli"

Status and phase

Completed

Phase 4

Conditions

Heart Failure, Congestive

Treatments

Drug: telmisartan

Study type

Interventional

Funder types

Other

Identifiers

NCT00490958

tchf-01-01

Details and patient eligibility

About

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.

Enrollment

351 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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