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OpenTrials
Completed

NCT Number: NCT00490958

Telmisartan in Haemodialysis Patients With Chronic Heart Failure

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.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chair of Cardiology Second University of Naples

Naples, 80100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan

Drug

Primary outcomes

  1. all cause mortality cardiovascular mortality hospitalization for decompensated heart failure

    Time frame: 36 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study 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

Important dates

Study start
1999
Study completion
2005
First posted
Jun 25, 2007
Registry last updated
Oct 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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