Telmisartan in Haemodialysis Patients With Chronic Heart Failure - Full Text View

Sponsored by:	Second University of Naples
Information provided by:	Second University of Naples
ClinicalTrials.gov Identifier:	NCT00490958

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 IV

MedlinePlus related topics: Dialysis Heart Failure Kidney Failure

Drug Information available for: Telmisartan

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Second University of Naples:

Primary Outcome Measures:

all cause mortality cardiovascular mortality hospitalization for decompensated heart failure [ Time Frame: 36 months ]

Secondary Outcome Measures:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490958

Locations

Italy
Chair of Cardiology Second University of Naples
Naples, Italy, 80100

Sponsors and Collaborators

Second University of Naples

Investigators

Study Chair:

Gennaro Cice, MD

Chair of cardiology Second University of Naples

More Information

No publications provided

Study ID Numbers:	tchf-01-01
Study First Received:	June 22, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00490958 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Second University of Naples:

heart Failure
haemodialysis
telmisartan
angiotensin converting enzyme inhibitor

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Heart Failure
Heart Diseases
Angiotensin-Converting Enzyme Inhibitors

Telmisartan
Angiotensin II
Protease Inhibitors

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Heart Failure
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors

Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009