Home Monitoring in Cardiac Resynchronisation Therapy
HomeCARE
Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy
1 other identifier
observational
513
10 countries
82
Brief Summary
In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have demonstrated that cardiac resynchronisation therapy (CRT) reduces mortality and rehospitalisation in heart failure patients. There is also evidence that telemonitoring of heart failure patients potentially reduces both mortality and morbidity. Recently, a Home Monitoring (HM) function has been integrated into BIOTRONIK CRT-defibrillators and CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote monitoring of heart failure patients. It is possible now to transmit predefined parameters on a daily basis from the implanted devices to a web-based platform accessible by patients' physicians. Our study evaluates clinical usefulness of Biotronik HM function in CRT-defibrillators and CRT-pacemakers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2005
Typical duration for all trials
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2006
CompletedFirst Posted
Study publicly available on registry
September 14, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedNovember 17, 2008
November 1, 2008
September 13, 2006
November 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sensitivity and specificity of (single or combined) HFM-parameters (onset of arrhythmias, duration of physical activity, mean heart rate at rest and over 24h, %CRT, lead impedance)
Predictive power of HFM-parameters regarding cardiovascular-based death or rehospitalisation (overnight stay)
Secondary Outcomes (5)
Effectiveness of HM (within sub-study)
Correlation of HM-values with the clinical status
Evaluation of the predictive power of HM parameters not implemented in the HFM and of parameters not transmitted by HM (diagnostic memory of device)
Sensitivity of HM-parameter regarding change of drug therapy
Incidence and reasons for HM-based interventions
Interventions
Eligibility Criteria
You may qualify if:
- Written patient informed consent
- Indication for CRT (biventricular or bifocal)
- Sufficient GSM-network coverage in the patient's area
- Stable residence during follow-up (anticipated)
- at least 1 documented hospitalisation due to heart failure within 12 months before enrolment
You may not qualify if:
- Permanent atrial fibrillation
- Myocardial infarction or instable Angina Pectoris within the last 3 months
- Planned cardiac interventions within the next 3 months (e.g. PTCA, CABG, HTX)
- Acute myocarditis
- Life expectancy under 6 months
- Pregnant or breast-feeding woman
- Participation in another clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
LKH-Universitätsklinikum Graz
Graz, 8036, Austria
Medizinische Universität Wien
Vienna, 1080, Austria
Fakultni nemocnice u Svety Anny
Brno, 65691, Czechia
IKEM
Prague, 14021, Czechia
Petr Neuzil M.D., Ph.D.
Prague, 155 00, Czechia
Centre Hospitalier Universitaire d'Angers
Angers, 49000, France
Hôpital Cardiologique du Haut Lévêque
Bordeaux, 33604, France
CHU de Lyon - Hôpital Louis Pradel
Lyon, 69394, France
Groupe Hospitalier de la Timone
Marseille, 13385, France
CHRU Hôpital de Villeneuve, Cardiologie A
Montpellier, 34295, France
CHRU Hôpital de Villeneuve, Cardiologie B
Montpellier, 34295, France
Centre Hospitalier
Pau, 64046, France
Hôpital haut Lévêque
Pessac, 33600, France
CHU des Rennes
Rennes, 35033, France
Universitätsklinik der RWTH Aachen
Aachen, 52074, Germany
Helios Klinikum Aue GmbH
Aue, 08280, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Krankenhaus Bassum
Bassum, 27211, Germany
Evangelisches Krankenhaus
Bergisch Gladbach, 51465, Germany
Gemeinschaftpraxis für Kardiologie und Angiologie
Bergisch Gladbach, 51465, Germany
Universitätsklinikum Charité
Berlin, 10117, Germany
Ambulantes Herzzentrum
Berlin, 12623, Germany
Franz-Volhard-Klinik
Berlin, 13125, Germany
Campus Virchow Klinikum, Charité
Berlin, 13355, Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 13437, Germany
Städtische Kliniken Bielefeld gGmbH
Bielefeld, 33604, Germany
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, 44789, Germany
Praxisgemeinschaft
Braunschweig, 38100, Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38118, Germany
Zentralkrankenhaus Links der Weser
Bremen, 28277, Germany
Kardiologische Gemeinschaftspraxis
Chemnitz, 09113, Germany
Klinikum Coburg
Coburg, 96450, Germany
Herzzentrum Coswig
Coswig, 06869, Germany
Carl-Thiem-Klinikum
Cottbus, 03048, Germany
Cardiac Research GmbH
Dortmund, 44225, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, 01067, Germany
Praxiszentrum Herzkreislauf
Dresden, 01219, Germany
Evangelisches Krankenhaus
Düsseldorf, 40217, Germany
Helios Klinikum Erfurt
Erfurt, 99089, Germany
Universitätsklinikum Essen
Essen, 45122, Germany
Elisabeth Krankenhaus Essen
Essen, 45138, Germany
Klinikum Frankfurt/Oder GmbH
Frankfurt (Oder), 15236, Germany
Ernst-Moritz-Arndt Universität Greifswald
Greifswald, 17489, Germany
Allgemeines Krankenhaus Altona
Hamburg, 22763, Germany
Kardiologische Gemeinschaftspraxis
Hanover, 30159, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Praxis Dr. med. Natour
Heidelberg, 69520, Germany
Medizinische Universitätsklinik Homburg/Saar
Homburg/Saar, 66424, Germany
Klinikum Hoyerswerda
Hoyerswerda, 02977, Germany
Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski
Kiel, 24116, Germany
Herzzentrum Konstanz GmbH
Konstanz, 78464, Germany
PD Dr. Christoph Karle
Künzelsau, 74653, Germany
Städtisches Klinikum St. Georg
Leipzig, 04129, Germany
Herzzentrum Leipzig GmbH
Leipzig, 04289, Germany
Märkische Kliniken GmbH
Lüdenscheid, 58515, Germany
Klinikum Johannes-Gutenberg-Universität
Mainz, 55131, Germany
Praxis Dr. Patrizia Kindler
Meiningen, 98617, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063, Germany
Stiftsklinik Augustinum
München, 81375, Germany
Ruppiner Klinikum GmbH
Neuruppin, 16816, Germany
Klinikum Pirna GmbH
Pirna, 01796, Germany
St. Adolf-Stift
Reinbek, 21465, Germany
St. Elisabeth Klinik
Saarlouis, 66740, Germany
Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm
Wittenberg/Lutherstadt, 06886, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Haemek Medical Center
Afula, 18101, Israel
Barzilai Medical Center, ICCU
Ashkelon, 78306, Israel
Ben Gurion University
Beersheba, 84170, Israel
Hadasit Medical Research Services & Development Ltd.
Jerusalem, 12000, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo
Allessandria, 15100, Italy
P. Stradina Clinical University Hospital
Riga, 1002, Latvia
VU Amsterdam
Amsterdam, 1081 HV, Netherlands
Erasmus Medical Center
Rotterdam, 3015, Netherlands
Zaandam Medisch Centrum
Zaandam, 1500 EE, Netherlands
Hospital Nra. Sra. de Sonsoles
Ávila, 5071, Spain
Selly Oak Hospital
Birmingham, B29 6JD, United Kingdom
St. Peter's Hospital / St. George's
Chertsey, KT 16 OQA, United Kingdom
Russels Hall Hospital
Dudley, DY1 2HQ, United Kingdom
University of Hull
Hull, HU16 5JQ, United Kingdom
Good Hope
Sutton Coldfield, B75 7RR, United Kingdom
Swansea NHS Trust
Swansea, SA6 6NL, United Kingdom
Related Publications (2)
Ellery S, Pakrashi T, Paul V, Sack S. Predicting mortality and rehospitalization in heart failure patients with home monitoring--the Home CARE pilot study. Clin Res Cardiol. 2006;95 Suppl 3:III29-35. doi: 10.1007/s00392-006-1306-6.
PMID: 16598601BACKGROUNDSack S, Wende CM, Nagele H, Katz A, Bauer WR, Barr CS, Malinowski K, Schwacke H, Leyva F, Proff J, Berdyshev S, Paul V. Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study. Eur J Heart Fail. 2011 Sep;13(9):1019-27. doi: 10.1093/eurjhf/hfr089.
PMID: 21852311DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Sack, Associate Prof. Dr.
Division of Cardiology, University of Essen, Germany
- PRINCIPAL INVESTIGATOR
Vincent Paul, MD
Cardiology Department, St. Peter's Hospital, Chertsey Surrey, United Kingdom
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2006
First Posted
September 14, 2006
Study Start
March 1, 2005
Study Completion
November 1, 2008
Last Updated
November 17, 2008
Record last verified: 2008-11