Home Monitoring in Cardiac Resynchronisation Therapy (HomeCARE)

November 14, 2008 updated by: Biotronik SE & Co. KG

Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

513

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • LKH-Universitätsklinikum Graz
      • Wien, Austria, 1080
        • Medizinische Universität Wien
  • Czech Republic
      • Brno, Czech Republic, 65691
        • Fakultni nemocnice u Svety Anny
      • Praha, Czech Republic, 14021
        • IKEM
      • Praha, Czech Republic, 155 00
        • Petr Neuzil M.D., Ph.D.
  • France
      • Angers, France, 49000
        • Centre hospitalier universitaire d'Angers
      • Bordeaux, France, 33604
        • Hôpital Cardiologique du Haut Lévêque
      • Lyon, France, 69394
        • CHU de Lyon - Hopital Louis Pradel
      • Marseille, France, 13385
        • Groupe Hospitalier de la Timone
      • Montpellier, France, 34295
        • CHRU Hôpital de Villeneuve, Cardiologie A
      • Montpellier, France, 34295
        • CHRU Hôpital de Villeneuve, Cardiologie B
      • Pau, France, 64046
        • Centre Hospitalier
      • Pessac, France, 33600
        • Hôpital Haut Lévêque
      • Rennes, France, 35033
        • CHU des Rennes
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinik der RWTH Aachen
      • Aue, Germany, 08280
        • Helios Klinikum Aue GmbH
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Bassum, Germany, 27211
        • Krankenhaus Bassum
      • Bergisch-Gladbach, Germany, 51465
        • Evangelisches Krankenhaus
      • Bergisch-Gladbach, Germany, 51465
        • Gemeinschaftpraxis für Kardiologie und Angiologie
      • Berlin, Germany, 10117
        • Universitätsklinikum Charité
      • Berlin, Germany, 12623
        • Ambulantes Herzzentrum
      • Berlin, Germany, 13125
        • Franz-Volhard-Klinik
      • Berlin, Germany, 13355
        • Campus Virchow Klinikum, Charité
      • Berlin, Germany, 13437
        • Vivantes Netzwerk für Gesundheit GmbH
      • Bielefeld, Germany, 33604
        • Städtische Kliniken Bielefeld gGmbH
      • Bochum, Germany, 44789
        • Berufsgenossenschaftliche Kliniken Bergmannsheil
      • Braunschweig, Germany, 38100
        • Praxisgemeinschaft
      • Braunschweig, Germany, 38118
        • Städtisches Klinikum Braunschweig gGmbH
      • Bremen, Germany, 28277
        • Zentralkrankenhaus Links der Weser
      • Chemnitz, Germany, 09113
        • Kardiologische Gemeinschaftspraxis
      • Coburg, Germany, 96450
        • Klinikum Coburg
      • Coswig, Germany, 06869
        • Herzzentrum Coswig
      • Cottbus, Germany, 03048
        • Carl-Thiem-Klinikum
      • Dortmund, Germany, 44225
        • Cardiac Research GmbH
      • Dresden, Germany, 01067
        • Städtisches Klinikum Dresden-Friedrichstadt
      • Dresden, Germany, 01219
        • Praxiszentrum Herzkreislauf
      • Düsseldorf, Germany, 40217
        • Evangelisches Krankenhaus
      • Erfurt, Germany, 99089
        • HELIOS Klinikum Erfurt
      • Essen, Germany, 45122
        • Universitatsklinikum Essen
      • Essen, Germany, 45138
        • Elisabeth Krankenhaus Essen
      • Frankfurt/Oder, Germany, 15236
        • Klinikum Frankfurt/Oder GmbH
      • Greifswald, Germany, 17489
        • Ernst-Moritz-Arndt Universität Greifswald
      • Hamburg, Germany, 22763
        • Allgemeines Krankenhaus Altona
      • Hannover, Germany, 30159
        • Kardiologische Gemeinschaftspraxis
      • Heidelberg, Germany, 69120
        • Universitatsklinikum Heidelberg
      • Heidelberg, Germany, 69520
        • Praxis Dr. med. Natour
      • Homburg/Saar, Germany, 66424
        • Medizinische Universitätsklinik Homburg/Saar
      • Hoyerswerda, Germany, 02977
        • Klinikum Hoyerswerda
      • Kiel, Germany, 24116
        • Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski
      • Konstanz, Germany, 78464
        • Herzzentrum Konstanz GmbH
      • Künzelsau, Germany, 74653
        • PD Dr. Christoph Karle
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig GmbH
      • Leipzig, Germany, 04129
        • Städtisches Klinikum St. Georg
      • Lüdenscheid, Germany, 58515
        • Märkische Kliniken GmbH
      • Mainz, Germany, 55131
        • Klinikum Johannes-Gutenberg-Universität
      • Meiningen, Germany, 98617
        • Praxis Dr. Patrizia Kindler
      • Mönchengladbach, Germany, 41063
        • Kliniken Maria Hilf GmbH
      • München, Germany, 81375
        • Stiftsklinik Augustinum
      • Neuruppin, Germany, 16816
        • Ruppiner Klinikum GmbH
      • Pirna, Germany, 01796
        • Klinikum Pirna GmbH
      • Reinbek, Germany, 21465
        • St. Adolf-Stift
      • Saarlouis, Germany, 66740
        • St. Elisabeth Klinik
      • Wittenberg/Lutherstadt, Germany, 06886
        • Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • Israel
      • Afula, Israel, 18101
        • Haemek Medical Center
      • Ashkelon, Israel, 78306
        • Barzilai Medical Center, ICCU
      • Beer Sheva, Israel, 84170
        • Ben Gurion University
      • Jerusalem, Israel, 12000
        • Hadasit Medical Research Services & Development Ltd.
      • Petach-Tikva, Israel, 49100
        • Rabin Medical Center
  • Italy
      • Allessandria, Italy, 15100
        • Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo
  • Latvia
      • Riga, Latvia, 1002
        • P. Stradina Clinical University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU Amsterdam
      • Rotterdam, Netherlands, 3015
        • Erasmus Medical Center
      • Zaandam, Netherlands, 1500 EE
        • Zaandam Medisch Centrum
  • Spain
      • Avila, Spain, 5071
        • Hospital Nra. Sra. de Sonsoles
  • United Kingdom
      • Birmingham, United Kingdom, B29 6JD
        • Selly Oak Hospital
      • Chertsey, United Kingdom, KT 16 OQA
        • St. Peter's Hospital / St. George's
      • Dudley, United Kingdom, DY1 2HQ
        • Russels Hall Hospital
      • Hull, United Kingdom, HU16 5JQ
        • University of Hull
      • Sutton Coldfield, United Kingdom, B75 7RR
        • Good Hope
      • Swansea, United Kingdom, SA6 6NL
        • Swansea NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Predictive power of HFM-parameters regarding cardiovascular-based death or rehospitalisation (overnight stay)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 14, 2006

Study Record Updates

Last Update Posted (Estimate)

November 17, 2008

Last Update Submitted That Met QC Criteria

November 14, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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