Document Detail


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).
MedLine Citation:
PMID:  18715826     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2008-08-19
Journal Detail:
Title:  European journal of heart failure     Volume:  10     ISSN:  1388-9842     ISO Abbreviation:  Eur. J. Heart Fail.     Publication Date:  2008 Sep 
Date Detail:
Created Date:  2008-09-16     Completed Date:  2009-01-27     Revised Date:  2011-06-08    
Medline Journal Info:
Nlm Unique ID:  100887595     Medline TA:  Eur J Heart Fail     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  907-16     Citation Subset:  IM    
Affiliation:
Karolinska Institutet, Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. frieder.braunschweig@karolinska.se
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MeSH Terms
Descriptor/Qualifier:
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:
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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