Home Monitoring in Cardiac Resynchronisation Therapy

Heart Failure, Congestive Clinical Trial

— HomeCARE  

Official title:

Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376116
• Other study ID #: TA056
• Status: Completed
• Phase: N/A
• First received: September 13, 2006
• Last updated: November 14, 2008
• Start date: March 2005
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• Cardiac resynchronisation therapy

• Implantable cardioverter-defibrillator

Locations

Country	Name	City	State
Austria	LKH-Universitätsklinikum Graz	Graz
Austria	Medizinische Universität Wien	Wien
Czech Republic	Fakultni nemocnice u Svety Anny	Brno
Czech Republic	IKEM	Praha
Czech Republic	Petr Neuzil M.D., Ph.D.	Praha
France	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
Germany	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	Ambulantes Herzzentrum	Berlin
Germany	Campus Virchow Klinikum, Charité	Berlin
Germany	Franz-Volhard-Klinik	Berlin
Germany	Universitätsklinikum 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	Praxiszentrum Herzkreislauf	Dresden
Germany	Städtisches Klinikum Dresden-Friedrichstadt	Dresden
Germany	Evangelisches Krankenhaus	Düsseldorf
Germany	Helios Klinikum Erfurt	Erfurt
Germany	Elisabeth Krankenhaus Essen	Essen
Germany	Universitätsklinikum Essen	Essen
Germany	Klinikum Frankfurt/Oder GmbH	Frankfurt/Oder
Germany	Ernst-Moritz-Arndt Universität Greifswald	Greifswald
Germany	Allgemeines Krankenhaus Altona	Hamburg
Germany	Kardiologische Gemeinschaftspraxis	Hannover
Germany	Praxis Dr. med. Natour	Heidelberg
Germany	Universitätsklinikum Heidelberg	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	Herzzentrum Leipzig GmbH	Leipzig
Germany	Städtisches Klinikum St. Georg	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
Israel	Haemek Medical Center	Afula
Israel	Barzilai Medical Center, ICCU	Ashkelon
Israel	Ben Gurion University	Beer Sheva
Israel	Hadasit Medical Research Services & Development Ltd.	Jerusalem
Israel	Rabin Medical Center	Petach-Tikva
Italy	Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo	Allessandria
Latvia	P. Stradina Clinical University Hospital	Riga
Netherlands	VU Amsterdam	Amsterdam
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Zaandam Medisch Centrum	Zaandam
Spain	Hospital Nra. Sra. de Sonsoles	Avila
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Czech Republic,  France,  Germany,  Israel,  Italy,  Latvia,  Netherlands,  Spain,  United Kingdom, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Predictive power of HFM-parameters regarding cardiovascular-based death or rehospitalisation (overnight stay)
Secondary	Effectiveness of HM (within sub-study)
Secondary	Correlation of HM-values with the clinical status
Secondary	Evaluation of the predictive power of HM parameters not implemented in the HFM and of parameters not transmitted by HM (diagnostic memory of device)
Secondary	Sensitivity of HM-parameter regarding change of drug therapy
Secondary	Incidence and reasons for HM-based interventions