Telmisartan in Haemodialysis Patients With Chronic Heart Failure
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure, Congestive |
Drug: telmisartan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
- all cause mortality cardiovascular mortality hospitalization for decompensated heart failure [ Time Frame: 36 months ]
- acute non-fatal myocardial infarction [ Time Frame: 36 months ]
- combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction) [ Time Frame: 36 months ]
- cardiovascular hospital admission [ Time Frame: 36 months ]
- nonfatal stroke [ Time Frame: 36 months ]
- coronary revascularization [ Time Frame: 36 months ]
- permanent premature treatment withdrawals [ Time Frame: 36 months ]
| Enrollment: | 351 |
| Study Start Date: | January 1999 |
| Study Completion Date: | June 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Italy | |
| Chair of Cardiology Second University of Naples | |
| Naples, Italy, 80100 | |
| Study Chair: | Gennaro Cice, MD | Chair of cardiology Second University of Naples |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00490958 History of Changes |
| Other Study ID Numbers: | tchf-01-01 |
| Study First Received: | June 22, 2007 |
| Last Updated: | October 16, 2008 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Second University of Naples:
|
heart Failure haemodialysis telmisartan angiotensin converting enzyme inhibitor |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Angiotensin-Converting Enzyme Inhibitors Telmisartan Enzyme Inhibitors Benzoates Protease Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013