A Phase 4 interventional study of telmisartan in Heart Failure, Congestive, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-17.
Sponsored by University of Campania Luigi Vanvitelli · Phase 4, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 351 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
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
This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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University of Campania Luigi Vanvitelli