Telmisartan in Haemodialysis Patients With Chronic Heart Failure

Phase 4

Completed

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00490958
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Study Completion: 2005-06
• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-22
• Study First Posted: 2007-06-25
• Status Verified: 2007-11
• Last Update Submitted: 2008-10-16
• Last Update Posted: 2008-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
all cause mortality cardiovascular mortality hospitalization for decompensated heart failure	36 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chair of Cardiology Second University of Naples; 🇮🇹 Naples, Italy