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Heart Failure, CongestiveHomeCARENCT00376116

Home Monitoring in Cardiac Resynchronisation Therapy

An observational study of Heart Failure, Congestive, run by Biotronik SE & Co. KG at 82 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Cardiac resynchronisation therapy and Implantable cardioverter-defibrillator
Type of treatment
Medical device
How many people
513 participants
Where
82 sitesin 10 countries
Study dates
Mar 2005to Nov 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

82 sites in 10 countries.

82 sites in 10 countries

Germany51 sites

  • Universitätsklinik der RWTH Aachen

    Aachen, 52074

  • Helios Klinikum Aue GmbH

    Aue, 08280

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

  • Krankenhaus Bassum

    Bassum, 27211

  • Evangelisches Krankenhaus

    Bergisch Gladbach, 51465

  • Gemeinschaftpraxis für Kardiologie und Angiologie

    Bergisch Gladbach, 51465

  • Universitätsklinikum Charité

    Berlin, 10117

  • Ambulantes Herzzentrum

    Berlin, 12623

  • Franz-Volhard-Klinik

    Berlin, 13125

  • Campus Virchow Klinikum, Charité

    Berlin, 13355

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 13437

  • Städtische Kliniken Bielefeld gGmbH

    Bielefeld, 33604

  • Berufsgenossenschaftliche Kliniken Bergmannsheil

    Bochum, 44789

  • Praxisgemeinschaft

    Braunschweig, 38100

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38118

  • Zentralkrankenhaus Links der Weser

    Bremen, 28277

  • Kardiologische Gemeinschaftspraxis

    Chemnitz, 09113

  • Klinikum Coburg

    Coburg, 96450

  • Herzzentrum Coswig

    Coswig, 06869

  • Carl-Thiem-Klinikum

    Cottbus, 03048

  • Cardiac Research GmbH

    Dortmund, 44225

  • Städtisches Klinikum Dresden-Friedrichstadt

    Dresden, 01067

  • Praxiszentrum Herzkreislauf

    Dresden, 01219

  • Evangelisches Krankenhaus

    Düsseldorf, 40217

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Universitätsklinikum Essen

    Essen, 45122

  • Elisabeth Krankenhaus Essen

    Essen, 45138

  • Klinikum Frankfurt/Oder GmbH

    Frankfurt (Oder), 15236

  • Ernst-Moritz-Arndt Universität Greifswald

    Greifswald, 17489

  • Allgemeines Krankenhaus Altona

    Hamburg, 22763

  • Kardiologische Gemeinschaftspraxis

    Hanover, 30159

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Praxis Dr. med. Natour

    Heidelberg, 69520

  • Medizinische Universitätsklinik Homburg/Saar

    Homburg/Saar, 66424

  • Klinikum Hoyerswerda

    Hoyerswerda, 02977

  • Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski

    Kiel, 24116

  • Herzzentrum Konstanz GmbH

    Konstanz, 78464

  • PD Dr. Christoph Karle

    Künzelsau, 74653

  • Städtisches Klinikum St. Georg

    Leipzig, 04129

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289

  • Märkische Kliniken GmbH

    Lüdenscheid, 58515

  • Klinikum Johannes-Gutenberg-Universität

    Mainz, 55131

  • Praxis Dr. Patrizia Kindler

    Meiningen, 98617

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

  • Stiftsklinik Augustinum

    München, 81375

  • Ruppiner Klinikum GmbH

    Neuruppin, 16816

  • Klinikum Pirna GmbH

    Pirna, 01796

  • St. Adolf-Stift

    Reinbek, 21465

  • St. Elisabeth Klinik

    Saarlouis, 66740

  • Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm

    Wittenberg/Lutherstadt, 06886

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

France9 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49000

  • Hôpital Cardiologique du Haut Lévêque

    Bordeaux, 33604

  • CHU de Lyon - Hôpital Louis Pradel

    Lyon, 69394

  • Groupe Hospitalier de la Timone

    Marseille, 13385

  • CHRU Hôpital de Villeneuve, Cardiologie A

    Montpellier, 34295

  • CHRU Hôpital de Villeneuve, Cardiologie B

    Montpellier, 34295

  • Centre Hospitalier

    Pau, 64046

  • Hôpital haut Lévêque

    Pessac, 33600

  • CHU des Rennes

    Rennes, 35033

Other trials in France

United Kingdom6 sites

  • Selly Oak Hospital

    Birmingham, B29 6JD

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

    Chertsey, KT 16 OQA

  • Russels Hall Hospital

    Dudley, DY1 2HQ

  • University of Hull

    Hull, HU16 5JQ

  • Good Hope

    Sutton Coldfield, B75 7RR

  • Swansea NHS Trust

    Swansea, SA6 6NL

Other trials in United Kingdom

Israel5 sites

  • Haemek Medical Center

    Afula, 18101

  • Barzilai Medical Center, ICCU

    Ashkelon, 78306

  • Ben Gurion University

    Beersheba, 84170

  • Hadasit Medical Research Services & Development Ltd.

    Jerusalem, 12000

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

Czechia3 sites

  • Fakultni nemocnice u Svety Anny

    Brno, 65691

  • IKEM

    Prague, 14021

  • Petr Neuzil M.D., Ph.D.

    Prague, 155 00

Other trials in Czechia

Netherlands3 sites

  • VU Amsterdam

    Amsterdam, 1081 HV

  • Erasmus Medical Center

    Rotterdam, 3015

  • Zaandam Medisch Centrum

    Zaandam, 1500 EE

Other trials in Netherlands

Austria2 sites

  • LKH-Universitätsklinikum Graz

    Graz, 8036

  • Medizinische Universität Wien

    Vienna, 1080

Other trials in Austria

Italy1 site

  • Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo

    Allessandria, 15100

Other trials in Italy

Latvia1 site

  • P. Stradina Clinical University Hospital

    Riga, 1002

Other trials in Latvia

Spain1 site

  • Hospital Nra. Sra. de Sonsoles

    Ávila, 5071

Other trials in Spain

About this study

Official title: 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.

Read the 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
Being tested
Cardiac resynchronisation therapy, Implantable cardioverter-defibrillator
Keywords
Implantable cardioverter-defibrillator, Pacemaker, Cardiac resynchronisation therapy, Heart failure, Predictor, Mortality, Rehospitalization, Telemedicine, Home Monitoring
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac resynchronisation therapyDevice

  • Implantable cardioverter-defibrillatorDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

Secondary outcomes (5)

  1. Effectiveness of HM (within sub-study)

  2. Correlation of HM-values with the clinical status

  3. Evaluation of the predictive power of HM parameters not implemented in the HFM and of parameters not transmitted by HM (diagnostic memory of device)

  4. Sensitivity of HM-parameter regarding change of drug therapy

  5. Incidence and reasons for HM-based interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2006 (estimated)
  2. Study startMar 2005
  3. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
513 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00376116
Sponsor's protocol ID
TA056
Acronym
HomeCARE
Status last verified
Nov 2008
First submitted
13 Sep 2006
Last updated
17 Nov 2008
Results posted
No

Publications

  • 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.

    PubMed 16598601

  • 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.

    PubMed 21852311

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, Congestive, run by Biotronik SE & Co. KG at 82 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in Germany, France, United Kingdom, Israel, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00376116, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2008.

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