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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) ☆
Author(s) -
Braunschweig Frieder,
Ford Ian,
Conraads Viviane,
Cowie Martin R.,
Jondeau Guillaume,
Kautzner Josef,
Lunati Maurizio,
Aguilera Roberto Munoz,
Yu Cheuk Man,
Marijianowski Monique,
Borggrefe Martin,
Veldhuisen Dirk J.
Publication year - 2008
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1016/j.ejheart.2008.06.016
Subject(s) - medicine , decompensation , heart failure , volume overload , clinical endpoint , cardiac resynchronization therapy , cardiology , randomized controlled trial , ambulatory , intensive care medicine , ejection fraction
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.