Telmisartan in Haemodialysis Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Drug: telmisartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: telmisartan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality cardiovascular mortality hospitalization for decompensated heart failure |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute non-fatal myocardial infarction |  | 36 months | 
| combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction) |  | 36 months | 
| cardiovascular hospital admission |  | 36 months | 
| nonfatal stroke |  | 36 months | 
| coronary revascularization |  | 36 months | 
| permanent premature treatment withdrawals |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart Failure, haemodialysis, telmisartan, angiotensin converting enzyme inhibitor