Clinical trial NCT00376116: Home Monitoring in Cardiac Resynchronisation Therapy
Official title: Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Keywords: Implantable cardioverter-defibrillator
Pacemaker
Cardiac resynchronisation therapy
Heart failure
Predictor
Mortality
Rehospitalization
Telemedicine
Home Monitoring
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2006-09-14
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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.

Detailed description: Clinical investigations identified potential predictors for mortality and rehospitalisation events in heart failure patients. A selection of these predictors primarily composes the "Heart Failure Monitor" (HFM), which is implemented in Biotronik implantable cardioverter defibrillators (ICDs) capable of delivering cardiac resynchronisation therapy (CRT) as well as in CRT-pacemakers. HFM and other parameters are transmitted to the attending physician via Home Monitoring (HM) function integrated in the implanted devices. In the future, a HFM with high predictive power may play an important role as part of a strategy of delivering effective health care for heart failure patients with an indication for CRT.

Our included patients implanted with CRT devices STRATOS LV-T (CRT-pacemaker), KRONOS LV-T, or Lumax HF-T (CRT-ICD). Pre-discharge protocol comprised standard device follow-up, activation of the HM-function, and assessment of complications and cardiovascular events. At follow-up controls 1, 3, 6, 9, and 12 months after implantation, standard device follow-up was performed and complications and cardiovascular events were assessed.

At enrollment, 6 and 12 months postoperative and in case of a rehospitalisation, the following parameters are documented:

* Echocardiographic parameters
* Quality of Life (Minnesota)
* ECG-parameters, NYHA-classification
* Blood pressure, body weight
* BNP / NT-pro BNP (optional)
* 6 minute walk test (optional)

At 1, 3 and 9 months postoperative:

* ECG-parameters, NYHA-classification
* Blood pressure, body weight
* BNP / NT-pro BNP (optional)
* 6 minute walk test (optional)

Further documentation:

* Change of drug treatment
* Any cardiovascular event and therapeutic intervention
* Heart failure related symptoms by means of patient diary

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
measure: Predictive power of HFM-parameters regarding cardiovascular-based death or rehospitalisation (overnight stay)
Secondary outcomes:
measure: Effectiveness of HM (within sub-study)
measure: Correlation of HM-values with the clinical status
measure: Evaluation of the predictive power of HM parameters not implemented in the HFM and of parameters not transmitted by HM (diagnostic memory of device)
measure: Sensitivity of HM-parameter regarding change of drug therapy
measure: Incidence and reasons for HM-based interventions
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Universitätsklinikum Graz
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Brno
country: Czech Republic
facility: Fakultni nemocnice u Svety Anny
city: Praha
country: Czech Republic
facility: IKEM
city: Praha
country: Czech Republic
facility: Petr Neuzil M.D., Ph.D.
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Bordeaux
country: France
facility: Hôpital Cardiologique du Haut Lévêque
city: Lyon
country: France
facility: CHU de Lyon - Hôpital Louis Pradel
city: Marseille
country: France
facility: Groupe Hospitalier de la Timone
city: Montpellier
country: France
facility: CHRU Hôpital de Villeneuve, Cardiologie A
city: Montpellier
country: France
facility: CHRU Hôpital de Villeneuve, Cardiologie B
city: Pau
country: France
facility: Centre Hospitalier
city: Pessac
country: France
facility: Hôpital haut Lévêque
city: Rennes
country: France
facility: CHU des Rennes
city: Aachen
country: Germany
facility: Universitätsklinik der RWTH Aachen
city: Aue
country: Germany
facility: Helios Klinikum Aue GmbH
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bassum
country: Germany
facility: Krankenhaus Bassum
city: Bergisch-Gladbach
country: Germany
facility: Evangelisches Krankenhaus
city: Bergisch-Gladbach
country: Germany
facility: Gemeinschaftpraxis für Kardiologie und Angiologie
city: Berlin
country: Germany
facility: Universitätsklinikum Charité
city: Berlin
country: Germany
facility: Ambulantes Herzzentrum
city: Berlin
country: Germany
facility: Franz-Volhard-Klinik
city: Berlin
country: Germany
facility: Campus Virchow Klinikum, Charité
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Bielefeld
country: Germany
facility: Städtische Kliniken Bielefeld gGmbH
city: Bochum
country: Germany
facility: Berufsgenossenschaftliche Kliniken Bergmannsheil
city: Braunschweig
country: Germany
facility: Praxisgemeinschaft
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH
city: Bremen
country: Germany
facility: Zentralkrankenhaus Links der Weser
city: Chemnitz
country: Germany
facility: Kardiologische Gemeinschaftspraxis
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Coswig
country: Germany
facility: Herzzentrum Coswig
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum
city: Dortmund
country: Germany
facility: Cardiac Research GmbH
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden-Friedrichstadt
city: Dresden
country: Germany
facility: Praxiszentrum Herzkreislauf
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen
city: Frankfurt/Oder
country: Germany
facility: Klinikum Frankfurt/Oder GmbH
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt Universität Greifswald
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Altona
city: Hannover
country: Germany
facility: Kardiologische Gemeinschaftspraxis
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Heidelberg
country: Germany
facility: Praxis Dr. med. Natour
city: Homburg/Saar
country: Germany
facility: Medizinische Universitätsklinik Homburg/Saar
city: Hoyerswerda
country: Germany
facility: Klinikum Hoyerswerda
city: Kiel
country: Germany
facility: Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski
city: Konstanz
country: Germany
facility: Herzzentrum Konstanz GmbH
city: Künzelsau
country: Germany
facility: PD Dr. Christoph Karle
city: Leipzig
country: Germany
facility: Städtisches Klinikum St. Georg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Lüdenscheid
country: Germany
facility: Märkische Kliniken GmbH
city: Mainz
country: Germany
facility: Klinikum Johannes-Gutenberg-Universität
city: Meiningen
country: Germany
facility: Praxis Dr. Patrizia Kindler
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: München
country: Germany
facility: Stiftsklinik Augustinum
city: Neuruppin
country: Germany
facility: Ruppiner Klinikum GmbH
city: Pirna
country: Germany
facility: Klinikum Pirna GmbH
city: Reinbek
country: Germany
facility: St. Adolf-Stift
city: Saarlouis
country: Germany
facility: St. Elisabeth Klinik
city: Wittenberg/Lutherstadt
country: Germany
facility: Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Afula
country: Israel
facility: Haemek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center, ICCU
city: Beer Sheva
country: Israel
facility: Ben Gurion University
city: Jerusalem
country: Israel
facility: Hadasit Medical Research Services & Development Ltd.
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center
city: Allessandria
country: Italy
facility: Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo
city: Riga
country: Latvia
facility: P. Stradina Clinical University Hospital
city: Amsterdam
country: Netherlands
facility: VU Amsterdam
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Zaandam
country: Netherlands
facility: Zaandam Medisch Centrum
city: Avila
country: Spain
facility: Hospital Nra. Sra. de Sonsoles
city: Birmingham
country: United Kingdom
facility: Selly Oak Hospital
city: Chertsey
country: United Kingdom
facility: St. Peter's Hospital / St. George's
city: Dudley
country: United Kingdom
facility: Russels Hall Hospital
city: Hull
country: United Kingdom
facility: University of Hull
city: Sutton Coldfield
country: United Kingdom
facility: Good Hope
city: Swansea
country: United Kingdom
facility: Swansea NHS Trust
Study officials:
affiliation: Division of Cardiology, University of Essen, Germany
name: Stefan Sack, Associate Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Department, St. Peter's Hospital, Chertsey Surrey, United Kingdom
name: Vincent Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sack 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.