| 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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MedLine Citation:
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PMID: 18715826 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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 2010 and to report in 2012. |
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Authors:
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Frieder Braunschweig; Ian Ford; Viviane Conraads; Martin R Cowie; Guillaume Jondeau; Josef Kautzner; Maurizio Lunati; Roberto Munoz Aguilera; Cheuk Man Yu; Monique Marijianowski; Martin Borggrefe; Dirk J van Veldhuisen; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2008-08-19 |
Journal Detail:
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Title: European journal of heart failure Volume: 10 ISSN: 1388-9842 ISO Abbreviation: Eur. J. Heart Fail. Publication Date: 2008 Sep |
Date Detail:
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Created Date: 2008-09-16 Completed Date: 2009-01-27 Revised Date: 2011-06-08 |
Medline Journal Info:
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Nlm Unique ID: 100887595 Medline TA: Eur J Heart Fail Country: Netherlands |
Other Details:
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Languages: eng Pagination: 907-16 Citation Subset: IM |
Affiliation:
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Karolinska Institutet, Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. frieder.braunschweig@karolinska.se |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Algorithms Cardiac Pacing, Artificial* Cardiography, Impedance* Chronic Disease Data Interpretation, Statistical Defibrillators, Implantable* Endpoint Determination Female Heart Failure / mortality*, physiopathology* Humans Male Monitoring, Ambulatory / instrumentation* Pulmonary Edema / diagnosis* Research Design* |
| Investigator | |
Investigator/Affiliation:
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M Borggrefe / ; D J van Veldhuisen / ; F Braunschweig / ; V Conraads / ; M R Cowie / ; I Ford Glasgow / ; G Jondeau / ; J Kautzner / ; R Muñoz-Aguilera / ; M Lunati / ; C M Yu / ; L Rydén / ; H Wedel / ; H J J Wellens / ; K Thygesen / ; B Uretsky / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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