Telmisartan in Haemodialysis Patients With Chronic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490958
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : October 17, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: telmisartan Phase 4

Study Type : Interventional  (Clinical Trial)
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 : January 1999
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan
U.S. FDA Resources

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00490958

Chair of Cardiology Second University of Naples
Naples, Italy, 80100
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Study Chair: Gennaro Cice, MD Chair of cardiology Second University of Naples

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00490958     History of Changes
Other Study ID Numbers: tchf-01-01
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: November 2007

Keywords provided by University of Campania "Luigi Vanvitelli":
heart Failure
angiotensin converting enzyme inhibitor

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors