HomeCARE: Home Monitoring in Cardiac Resynchronisation Therapy

Sponsor

Biotronik SE & Co. KG (Industry)

Overall Status

Completed

CT.gov ID

NCT00376116

Collaborator

(none)

513

Enrollment

Locations

44.1

Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive	Device: Cardiac resynchronisation therapy Device: Implantable cardioverter-defibrillator

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 Design

Study Type:

Observational

Actual Enrollment :

513 participants

Time Perspective:

Prospective

Official Title:

Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

Study Start Date :

Mar 1, 2005

Actual Study Completion Date :

Nov 1, 2008

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	LKH-Universitätsklinikum Graz	Graz	Austria	8036
2	Medizinische Universität Wien	Wien	Austria	1080
3	Fakultni nemocnice u Svety Anny	Brno	Czech Republic	65691
4	IKEM	Praha	Czech Republic	14021
5	Petr Neuzil M.D., Ph.D.	Praha	Czech Republic	155 00
6	Centre Hospitalier Universitaire d'Angers	Angers	France	49000
7	Hôpital Cardiologique du Haut Lévêque	Bordeaux	France	33604
8	CHU de Lyon - Hôpital Louis Pradel	Lyon	France	69394
9	Groupe Hospitalier de la Timone	Marseille	France	13385
10	CHRU Hôpital de Villeneuve, Cardiologie A	Montpellier	France	34295
11	CHRU Hôpital de Villeneuve, Cardiologie B	Montpellier	France	34295
12	Centre Hospitalier	Pau	France	64046
13	Hôpital haut Lévêque	Pessac	France	33600
14	CHU des Rennes	Rennes	France	35033
15	Universitätsklinik der RWTH Aachen	Aachen	Germany	52074
16	Helios Klinikum Aue GmbH	Aue	Germany	08280
17	Zentralklinik Bad Berka GmbH	Bad Berka	Germany	99437
18	Krankenhaus Bassum	Bassum	Germany	27211
19	Evangelisches Krankenhaus	Bergisch-Gladbach	Germany	51465
20	Gemeinschaftpraxis für Kardiologie und Angiologie	Bergisch-Gladbach	Germany	51465
21	Universitätsklinikum Charité	Berlin	Germany	10117
22	Ambulantes Herzzentrum	Berlin	Germany	12623
23	Franz-Volhard-Klinik	Berlin	Germany	13125
24	Campus Virchow Klinikum, Charité	Berlin	Germany	13355
25	Vivantes Netzwerk für Gesundheit GmbH	Berlin	Germany	13437
26	Städtische Kliniken Bielefeld gGmbH	Bielefeld	Germany	33604
27	Berufsgenossenschaftliche Kliniken Bergmannsheil	Bochum	Germany	44789
28	Praxisgemeinschaft	Braunschweig	Germany	38100
29	Städtisches Klinikum Braunschweig gGmbH	Braunschweig	Germany	38118
30	Zentralkrankenhaus Links der Weser	Bremen	Germany	28277
31	Kardiologische Gemeinschaftspraxis	Chemnitz	Germany	09113
32	Klinikum Coburg	Coburg	Germany	96450
33	Herzzentrum Coswig	Coswig	Germany	06869
34	Carl-Thiem-Klinikum	Cottbus	Germany	03048
35	Cardiac Research GmbH	Dortmund	Germany	44225
36	Städtisches Klinikum Dresden-Friedrichstadt	Dresden	Germany	01067
37	Praxiszentrum Herzkreislauf	Dresden	Germany	01219
38	Evangelisches Krankenhaus	Düsseldorf	Germany	40217
39	Helios Klinikum Erfurt	Erfurt	Germany	99089
40	Universitätsklinikum Essen	Essen	Germany	45122
41	Elisabeth Krankenhaus Essen	Essen	Germany	45138
42	Klinikum Frankfurt/Oder GmbH	Frankfurt/Oder	Germany	15236
43	Ernst-Moritz-Arndt Universität Greifswald	Greifswald	Germany	17489
44	Allgemeines Krankenhaus Altona	Hamburg	Germany	22763
45	Kardiologische Gemeinschaftspraxis	Hannover	Germany	30159
46	Universitätsklinikum Heidelberg	Heidelberg	Germany	69120
47	Praxis Dr. med. Natour	Heidelberg	Germany	69520
48	Medizinische Universitätsklinik Homburg/Saar	Homburg/Saar	Germany	66424
49	Klinikum Hoyerswerda	Hoyerswerda	Germany	02977
50	Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski	Kiel	Germany	24116
51	Herzzentrum Konstanz GmbH	Konstanz	Germany	78464
52	PD Dr. Christoph Karle	Künzelsau	Germany	74653
53	Städtisches Klinikum St. Georg	Leipzig	Germany	04129
54	Herzzentrum Leipzig GmbH	Leipzig	Germany	04289
55	Märkische Kliniken GmbH	Lüdenscheid	Germany	58515
56	Klinikum Johannes-Gutenberg-Universität	Mainz	Germany	55131
57	Praxis Dr. Patrizia Kindler	Meiningen	Germany	98617
58	Kliniken Maria Hilf GmbH	Mönchengladbach	Germany	41063
59	Stiftsklinik Augustinum	München	Germany	81375
60	Ruppiner Klinikum GmbH	Neuruppin	Germany	16816
61	Klinikum Pirna GmbH	Pirna	Germany	01796
62	St. Adolf-Stift	Reinbek	Germany	21465
63	St. Elisabeth Klinik	Saarlouis	Germany	66740
64	Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm	Wittenberg/Lutherstadt	Germany	06886
65	Universitätsklinikum Würzburg	Würzburg	Germany	97080
66	Haemek Medical Center	Afula	Israel	18101
67	Barzilai Medical Center, ICCU	Ashkelon	Israel	78306
68	Ben Gurion University	Beer Sheva	Israel	84170
69	Hadasit Medical Research Services & Development Ltd.	Jerusalem	Israel	12000
70	Rabin Medical Center	Petach-Tikva	Israel	49100
71	Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo	Allessandria	Italy	15100
72	P. Stradina Clinical University Hospital	Riga	Latvia	1002
73	VU Amsterdam	Amsterdam	Netherlands	1081 HV
74	Erasmus Medical Center	Rotterdam	Netherlands	3015
75	Zaandam Medisch Centrum	Zaandam	Netherlands	1500 EE
76	Hospital Nra. Sra. de Sonsoles	Avila	Spain	5071
77	Selly Oak Hospital	Birmingham	United Kingdom	B29 6JD
78	St. Peter's Hospital / St. George's	Chertsey	United Kingdom	KT 16 OQA
79	Russels Hall Hospital	Dudley	United Kingdom	DY1 2HQ
80	University of Hull	Hull	United Kingdom	HU16 5JQ
81	Good Hope	Sutton Coldfield	United Kingdom	B75 7RR
82	Swansea NHS Trust	Swansea	United Kingdom	SA6 6NL

Sponsors and Collaborators

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