Telmisartan in Haemodialysis Patients With Chronic Heart Failure

Sponsor

University of Campania "Luigi Vanvitelli" (Other)

Overall Status

Completed

CT.gov ID

NCT00490958

Collaborator

(none)

351

Enrollment

Location

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive	Drug: telmisartan	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

351 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 1999

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

all cause mortality cardiovascular mortality hospitalization for decompensated heart failure [36 months]

Secondary Outcome Measures

acute non-fatal myocardial infarction [36 months]
combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction) [36 months]
cardiovascular hospital admission [36 months]
nonfatal stroke [36 months]
coronary revascularization [36 months]
permanent premature treatment withdrawals [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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