Heart Failure, Congestive
Conditions
Keywords
heart Failure, haemodialysis, telmisartan, angiotensin converting enzyme inhibitor
Brief summary
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.
Interventions
DRUGtelmisartan
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality cardiovascular mortality hospitalization for decompensated heart failure | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction) | 36 months |
| cardiovascular hospital admission | 36 months |
| acute non-fatal myocardial infarction | 36 months |
| coronary revascularization | 36 months |
| permanent premature treatment withdrawals | 36 months |
| nonfatal stroke | 36 months |
Countries
Italy
Outcome results
None listed