Clinical trial NCT00490958: Telmisartan in Haemodialysis Patients With Chronic Heart Failure
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure, Congestive
Keywords: heart Failure
haemodialysis
telmisartan
angiotensin converting enzyme inhibitor
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2007-06-25
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: all cause mortality cardiovascular mortality hospitalization for decompensated heart failure
timeFrame: 36 months
Secondary outcomes:
measure: acute non-fatal myocardial infarction
timeFrame: 36 months
measure: combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)
timeFrame: 36 months
measure: cardiovascular hospital admission
timeFrame: 36 months
measure: nonfatal stroke
timeFrame: 36 months
measure: coronary revascularization
timeFrame: 36 months
measure: permanent premature treatment withdrawals
timeFrame: 36 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Chair of Cardiology Second University of Naples
Study officials:
affiliation: Chair of cardiology Second University of Naples
name: Gennaro Cice, MD
role: STUDY_CHAIR
References:
citation: Cice G, Di Benedetto A, D'Isa S, D'Andrea A, Marcelli D, Gatti E, Calabro R. Effects of telmisartan added to Angiotensin-converting enzyme inhibitors on mortality and morbidity in hemodialysis patients with chronic heart failure a double-blind, placebo-controlled trial. J Am Coll Cardiol. 2010 Nov 16;56(21):1701-8. doi: 10.1016/j.jacc.2010.03.105.