Home Monitoring in Cardiac Resynchronisation Therapy

NCT ID: NCT00376116

Last Updated: 2008-11-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 513 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-11-30

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

Conditions

Heart Failure, Congestive

Keywords

Implantable cardioverter-defibrillator; Pacemaker; Cardiac resynchronisation therapy; Heart failure; Predictor; Mortality; Rehospitalization; Telemedicine; Home Monitoring

Study Design

• Study Time Perspective: PROSPECTIVE

Interventions

Cardiac resynchronisation therapy

Intervention Type: DEVICE

Implantable cardioverter-defibrillator

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Principal Investigators

Stefan Sack, Associate Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, University of Essen, Germany

Vincent Paul, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Department, St. Peter's Hospital, Chertsey Surrey, United Kingdom

Locations

LKH-Universitätsklinikum Graz

Graz, , Austria

Medizinische Universität Wien

Vienna, , Austria

Fakultni nemocnice u Svety Anny

Brno, , Czechia

IKEM

Prague, , Czechia

Petr Neuzil M.D., Ph.D.

Prague, , Czechia

Centre Hospitalier Universitaire d'Angers

Angers, , France

Hôpital Cardiologique du Haut Lévêque

Bordeaux, , France

CHU de Lyon - Hôpital Louis Pradel

Lyon, , France

Groupe Hospitalier de la Timone

Marseille, , France

CHRU Hôpital de Villeneuve, Cardiologie A

Montpellier, , France

CHRU Hôpital de Villeneuve, Cardiologie B

Montpellier, , France

Centre Hospitalier

Pau, , France

Hôpital haut Lévêque

Pessac, , France

CHU des Rennes

Rennes, , France

Universitätsklinik der RWTH Aachen

Aachen, , Germany

Helios Klinikum Aue GmbH

Aue, , Germany

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Krankenhaus Bassum

Bassum, , Germany

Evangelisches Krankenhaus

Bergisch Gladbach, , Germany

Gemeinschaftpraxis für Kardiologie und Angiologie

Bergisch Gladbach, , Germany

Universitätsklinikum Charité

Berlin, , Germany

Ambulantes Herzzentrum

Berlin, , Germany

Franz-Volhard-Klinik

Berlin, , Germany

Campus Virchow Klinikum, Charité

Berlin, , Germany

Vivantes Netzwerk für Gesundheit GmbH

Berlin, , Germany

Städtische Kliniken Bielefeld gGmbH

Bielefeld, , Germany

Berufsgenossenschaftliche Kliniken Bergmannsheil

Bochum, , Germany

Praxisgemeinschaft

Braunschweig, , Germany

Städtisches Klinikum Braunschweig gGmbH

Braunschweig, , Germany

Zentralkrankenhaus Links der Weser

Bremen, , Germany

Kardiologische Gemeinschaftspraxis

Chemnitz, , Germany

Klinikum Coburg

Coburg, , Germany

Herzzentrum Coswig

Coswig, , Germany

Carl-Thiem-Klinikum

Cottbus, , Germany

Cardiac Research GmbH

Dortmund, , Germany

Städtisches Klinikum Dresden-Friedrichstadt

Dresden, , Germany

Praxiszentrum Herzkreislauf

Dresden, , Germany

Evangelisches Krankenhaus

Düsseldorf, , Germany

Helios Klinikum Erfurt

Erfurt, , Germany

Universitätsklinikum Essen

Essen, , Germany

Elisabeth Krankenhaus Essen

Essen, , Germany

Klinikum Frankfurt/Oder GmbH

Frankfurt (Oder), , Germany

Ernst-Moritz-Arndt Universität Greifswald

Greifswald, , Germany

Allgemeines Krankenhaus Altona

Hamburg, , Germany

Kardiologische Gemeinschaftspraxis

Hanover, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Praxis Dr. med. Natour

Heidelberg, , Germany

Medizinische Universitätsklinik Homburg/Saar

Homburg/Saar, , Germany

Klinikum Hoyerswerda

Hoyerswerda, , Germany

Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski

Kiel, , Germany

Herzzentrum Konstanz GmbH

Konstanz, , Germany

PD Dr. Christoph Karle

Künzelsau, , Germany

Städtisches Klinikum St. Georg

Leipzig, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Märkische Kliniken GmbH

Lüdenscheid, , Germany

Klinikum Johannes-Gutenberg-Universität

Mainz, , Germany

Praxis Dr. Patrizia Kindler

Meiningen, , Germany

Kliniken Maria Hilf GmbH

Mönchengladbach, , Germany

Stiftsklinik Augustinum

München, , Germany

Ruppiner Klinikum GmbH

Neuruppin, , Germany

Klinikum Pirna GmbH

Pirna, , Germany

St. Adolf-Stift

Reinbek, , Germany

St. Elisabeth Klinik

Saarlouis, , Germany

Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm

Wittenberg/Lutherstadt, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Haemek Medical Center

Afula, , Israel

Barzilai Medical Center, ICCU

Ashkelon, , Israel

Ben Gurion University

Beersheba, , Israel

Hadasit Medical Research Services & Development Ltd.

Jerusalem, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo

Allessandria, , Italy

P. Stradina Clinical University Hospital

Riga, , Latvia

VU Amsterdam

Amsterdam, , Netherlands

Erasmus Medical Center

Rotterdam, , Netherlands

Zaandam Medisch Centrum

Zaandam, , Netherlands

Hospital Nra. Sra. de Sonsoles

Ávila, , Spain

Selly Oak Hospital

Birmingham, , United Kingdom

St. Peter's Hospital / St. George's

Chertsey, , United Kingdom

Russels Hall Hospital

Dudley, , United Kingdom

University of Hull

Hull, , United Kingdom

Good Hope

Sutton Coldfield, , United Kingdom

Swansea NHS Trust

Swansea, , United Kingdom

Countries

Austria; Czechia; France; Germany; Israel; Italy; Latvia; Netherlands; Spain; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 16598601 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21852311 (View on PubMed)

Other Identifiers

TA056

Identifier Type: -

Identifier Source: org_study_id