Telmisartan in Haemodialysis Patients With Chronic Heart Failure
Information source: Second University of Naples
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure, Congestive
Intervention: telmisartan (Drug)
Phase: Phase 4
Sponsored by: Second University of Naples
Official(s) and/or principal investigator(s):
Gennaro Cice, MD, Study Chair, Affiliation: Chair of cardiology Second University of Naples
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
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
Results: At three years, telmisartan significantly reduced all-cause mortality (35. 1% versus
54. 4%; p<0. 001), cardiovascular death (30. 3% versus 43. 7%; p<0. 001), and hospital admission
for CHF (33. 9% versus 55. 1%; p<0. 0001). Using Cox's proportional-hazards regression analysis,
telmisartan appeared to be an independent determinant of all-cause mortality (HR: 0. 51; 95%
CI: 0. 32-0. 82; p<0. 01), cardiovascular mortality (HR 0. 42; 95% CI: 0. 38-0. 61; p<0. 0001) and
hospitalization for deterioration of heart failure (HR: 0. 38; 95% CI: 0. 19-0. 51; p<0. 0001).
Adverse effects, mainly hypotension, occurred in 16. 3% of the telmisartan group versus 10. 7%
in the placebo group.
Conclusions: Addition of telmisartan to standard therapies significantly reduces all-cause
mortality, cardiovascular death and heart failure hospitalizations in haemodialysis patients
with CHF and LVEF 40%.
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: all cause mortality
hospitalization for decompensated heart failure
acute non-fatal myocardial infarction
combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)
cardiovascular hospital admission
permanent premature treatment withdrawals
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- Hypotension during dialysis;
- Atrial fibrillation;
- Intolerant to low dose of telmisartan
Locations and Contacts
Chair of Cardiology Second University of Naples, Naples 80100, Italy
Starting date: January 1999
Ending date: June 2005
Last updated: November 16, 2007