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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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|
- all cause mortality cardiovascular mortality hospitalization for decompensated heart failure [ Time Frame: 36 months ]
- 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 ]
|Study Start Date:||January 1999|
|Study Completion Date:||June 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490958
|Chair of Cardiology Second University of Naples|
|Naples, Italy, 80100|
|Study Chair:||Gennaro Cice, MD||Chair of cardiology Second University of Naples|