Telmisartan in Haemodialysis Patients With Chronic Heart Failure
NCT ID: NCT00490958
Last Updated: 2008-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
351 participants
INTERVENTIONAL
1999-01-31
2005-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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telmisartan
Eligibility Criteria
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Inclusion Criteria
* 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
* Atrial fibrillation;
* Intolerant to low dose of telmisartan
18 Years
ALL
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Principal Investigators
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Gennaro Cice, MD
Role: STUDY_CHAIR
Chair of cardiology Second University of Naples
Locations
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Chair of Cardiology Second University of Naples
Naples, , Italy
Countries
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References
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Cice G, Di Benedetto A, D'Isa S, D'Andrea A, Marcelli D, Gatti E, Calabro R. Effects of telmisartan added to Angiotensin-converting enzyme inhibitors on mortality and morbidity in hemodialysis patients with chronic heart failure a double-blind, placebo-controlled trial. J Am Coll Cardiol. 2010 Nov 16;56(21):1701-8. doi: 10.1016/j.jacc.2010.03.105.
Other Identifiers
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tchf-01-01
Identifier Type: -
Identifier Source: org_study_id