|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Second University of Naples |
|---|---|
| Information provided by: | Second University of Naples |
| ClinicalTrials.gov Identifier: | NCT00490958 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Chair of Cardiology Second University of Naples | |
| Naples, Italy, 80100 | |
| Study Chair: | Gennaro Cice, MD | Chair of cardiology Second University of Naples |
More Information
| Study ID Numbers: | tchf-01-01 |
| Study First Received: | June 22, 2007 |
| Last Updated: | October 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00490958 History of Changes |
| Health Authority: | Italy: Ministry of Health |
|
heart Failure haemodialysis telmisartan angiotensin converting enzyme inhibitor |
|
Angiotensin II Type 1 Receptor Blockers Heart Failure Heart Diseases Molecular Mechanisms of Pharmacological Action Angiotensin-Converting Enzyme Inhibitors |
Enzyme Inhibitors Cardiovascular Diseases Telmisartan Pharmacologic Actions Protease Inhibitors |
