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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality cardiovascular mortality hospitalization for decompensated heart failure | 36 months |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gennaro Cice, MD | Chair of cardiology Second University of Naples | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chair of Cardiology Second University of Naples | Naples | 80100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21070920 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| cardiovascular hospital admission |
| 36 months |
| nonfatal stroke | 36 months |
| coronary revascularization | 36 months |
| permanent premature treatment withdrawals | 36 months |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |