Telmisartan in Haemodialysis Patients With Chronic Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT00490958
First received: June 22, 2007
Last updated: October 16, 2008
Last verified: November 2007
  Purpose

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 Intervention Phase
Heart Failure, Congestive
Drug: telmisartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • all cause mortality cardiovascular mortality hospitalization for decompensated heart failure [ Time Frame: 36 months ]

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

Enrollment: 351
Study Start Date: January 1999
Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490958

Locations
Italy
Chair of Cardiology Second University of Naples
Naples, Italy, 80100
Sponsors and Collaborators
Second University of Naples
Investigators
Study Chair: Gennaro Cice, MD Chair of cardiology Second University of Naples
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00490958     History of Changes
Other Study ID Numbers: tchf-01-01
Study First Received: June 22, 2007
Last Updated: October 16, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by Second University of Naples:
heart Failure
haemodialysis
telmisartan
angiotensin converting enzyme inhibitor

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Telmisartan
Enzyme Inhibitors
Benzoates
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014