Telmisartan in Haemodialysis Patients With Chronic Heart Failure

Condition(s) targeted: Heart Failure, Congestive

Intervention: telmisartan (Drug)

Phase: Phase 4

Status: Completed

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 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.

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 cardiovascular mortality hospitalization for decompensated heart failure

Secondary outcome:

acute non-fatal myocardial infarction

combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)

cardiovascular hospital admission

nonfatal stroke

coronary revascularization

permanent premature treatment withdrawals

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

randomization

Exclusion Criteria:

- Hypotension during dialysis;

- Atrial fibrillation;

- Intolerant to low dose of telmisartan

Chair of Cardiology Second University of Naples, Naples 80100, Italy

Starting date: January 1999
Ending date: June 2005
Last updated: November 16, 2007