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Title
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Can monitoring of intrathoracic impedance reduce morbidity and mortality in patients with chronic heart failure? Rationale and design of the Diagnostic outcome Trial in Heart Failure (DOT-HF)
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Author
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Abstract
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| Background: Chronic heart failure is associated with frequent hospitalisations which are often due to volume-overload decompensation. Monitoring of intrathoracic impedance, measured from an implanted device, can detect increases in pulmonary fluid retention early and facilitate timely treatment interventions. Objective: The DOT-HF trial is designed to investigate if ambulatory monitoring of intrathoracic impedance together with other device-based diagnostic information can reduce morbidity and mortality in patients with chronic heart failure who are treated with cardiac resynchronization therapy (CRT) and/or an implantable defibrillator (ICD). Methods: Approximately 2400 patients will be randomised in a 1: 1 fashion to a management strategy with access to the diagnostic information from the implantable device ("access arm"), or a "control arm", where this information is not made available. Study subjects fulfil standard indications for CRT and/or ICD as outlined in current guidelines. In the access arm, a fluid alert algorithm is used to give early warning of decreasing intrathoracic impedance indicating a high risk of an impending volume-overload decompensation. The primary endpoint of DOT-HF is the composite of all-cause mortality or heart failure hospitalisation. Secondary and exploratory endpoints include all-cause mortality, the impact on total health care utilization, quality of life and cost effectiveness. The study is expected to close recruitment during 20 10 and to report in 2012. |
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Language
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English
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Source (journal)
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European journal of heart failure. - Place of publication unknown
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Publication
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Place of publication unknown
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2008
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ISSN
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1388-9842
[Print]
1879-0844
[Online]
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DOI
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10.1016/J.EJHEART.2008.06.016
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Volume/pages
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10
:9
(2008)
, p. 907-916
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ISI
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000260275000013
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Full text (Publisher's DOI)
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