title: 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).
abstract: 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: Karolinska Institutet, Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. frieder.braunschweig@karolinska.se
authors: Frieder
authors: F
authors: Braunschweig
authors: Ian
authors: I
authors: Ford
authors: Viviane
authors: V
authors: Conraads
authors: Martin R
authors: MR
authors: Cowie
authors: Guillaume
authors: G
authors: Jondeau
authors: Josef
authors: J
authors: Kautzner
authors: Maurizio
authors: M
authors: Lunati
authors: Roberto
authors: R
authors: Munoz Aguilera
authors: Cheuk
authors: C
authors: Man Yu
authors: Monique
authors: M
authors: Marijianowski
authors: Martin
authors: M
authors: Borggrefe
authors: Dirk J
authors: DJ
authors: van Veldhuisen
mesh_terms: D000465:Algorithms; D002304:Cardiac Pacing, Artificial; D002307:Cardiography, Impedance; D002908:Chronic Disease; D003627:Data Interpretation, Statistical; D017147:Defibrillators, Implantable; D023381:Endpoint Determination; D005260:Female; D006333:Heart Failure / Q000401:mortality* / Q000503:physiopathology*; D006801:Humans; D008297:Male; D018670:Monitoring, Ambulatory / Q000295:instrumentation*; D011654:Pulmonary Edema / Q000175:diagnosis*; D012107:Research Design