NCT00711360|CompletedPhase 4
Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II)
HomeCARE II
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HomeCARE II
Sponsor study identifier
Secondary identifiers
interventional
303
3 countries
28
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Actual (reported)Study Completion
September 2012
Actual (reported)The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. In future, this will allow for automatic early detection of imminent decompensation at a presymptomatic stage and immediate initialization of clinical meaningful therapeutic interventions preventing heart failure related hospitalizations. The aim of this investigation is to record long-term impedance trends in heart failure patients with and without heart failure related events (hospitalizations due to acute decompensation) in order to develop algorithms for device-based early detection and warning of HF deterioration accompanied by pulmonary congestion.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 7, 2008
Actual (reported)July 8, 2008
Actual (reported)January 2012
Actual (reported)September 2012
Actual (reported)Long-term impedance trends in patients with clinically relevant heart failure events, to support the development of impedance based detection algorithms. A posterior assessment of sensitivity and false alarm rate of the detection algorithms.
Study will last until 35 heart failure events are collected
Further improvement of the Heart Failure Monitor based on collected data
The same as for primary outcome measure
Intrathoracic impedance measurement by cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs) (Lumax 540)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
RWTH Medizinische Klinik I Aachen
Aachen, Germany
Klinikum Aschaffenburg
Aschaffenburg, Germany
Kerckhoff-Klinik GmbH Bad Nauheim
Bad Nauheim, Germany
Herz- und Gefäss-Klinik GmbH Bad Neustadt
Bad Neustadt A. D. Saale, Germany
HDZ Bad Oeynhausen NRW
Bad Oeynhausen, Germany
Universitätsklinikum Benjamin Franklin
Berlin, Germany
Berufsgenossenschaftliche Kliniken Bergmannsheil Universität Bochum
Bochum, Germany
Maier SKG, Paule S, Jung W, Koller M, Ventura R, Quesada A, Bordachar P, Garcia-Fernandez FJ, Schumacher B, Lobitz N, Takizawa K, Ando K, Adachi K, Shoda M. Evaluation of thoracic impedance trends for implant-based remote monitoring in heart failure patients - Results from the (J-)HomeCARE-II Study. J Electrocardiol. 2019 Mar-Apr;53:100-108. doi: 10.1016/j.jelectrocard.2019.01.004. Epub 2019 Jan 25.
Sebastian Maier, PD Dr. med.
Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany
303 participants (actual enrollment reported by the registry).
First Submitted
July 7, 2008
First Posted
July 8, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Kliniken Erlabrunn gGmbH
Breitenbrunn, Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Ernst-Moritz-Arndt Universität Greifswald
Greifswald, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Medizinische Universitätsklinik Heidelberg
Heidelberg, Germany
Universitätsklinikum Jena
Jena, Germany
Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
Neuss, Germany
Marienhospital Osnabrück GmbH
Osnabrück, Germany
Marienkrankenhaus Papenburg-Aschendorf GmbH
Papenburg, Germany
St. Elisabeth Klinik Saarlouis
Saarlouis, Germany
Krankenhaus der Evangelischen Diakonissenanstalt
Speyer, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Kliniken Villingen
Villingen, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Hospital General Yagüe
Burgos, Spain
Hospital de Donostia
Donostia / San Sebastian, Spain
Hospital General universitario Valencia
Valencia, Spain
Cardio Centro Ticino
Lugano, Switzerland
Primary Completion
January 2012
Actual (reported)Study Completion
September 2012
Actual (reported)Last Updated
September 26, 2012
Record last verified: 2012-09
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