Telmisartan in Haemodialysis Patients With Chronic Heart Failure

October 16, 2008 updated by: University of Campania "Luigi Vanvitelli"

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

351

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • Chair of Cardiology Second University of Naples

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality cardiovascular mortality hospitalization for decompensated heart failure
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
acute non-fatal myocardial infarction
Time Frame: 36 months
36 months
combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)
Time Frame: 36 months
36 months
cardiovascular hospital admission
Time Frame: 36 months
36 months
nonfatal stroke
Time Frame: 36 months
36 months
coronary revascularization
Time Frame: 36 months
36 months
permanent premature treatment withdrawals
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Investigators

  • Study Chair: Gennaro Cice, MD, Chair of Cardiology Second University of Naples

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

June 22, 2007

First Submitted That Met QC Criteria

June 22, 2007

First Posted (Estimate)

June 25, 2007

Study Record Updates

Last Update Posted (Estimate)

October 17, 2008

Last Update Submitted That Met QC Criteria

October 16, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tchf-01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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