Home Monitoring in Cardiac Resynchronisation Therapy

Completed

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00376116
• Lead Sponsor: Biotronik SE & Co. KG

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

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-14
• Status Verified: 2008-11
• Study Completion: 2008-11
• Last Update Submitted: 2008-11-14
• Last Update Posted: 2008-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (80)

CHRU Hôpital de Villeneuve, Cardiologie A; 🇫🇷 Montpellier, France

Universitätsklinik der RWTH Aachen; 🇩🇪 Aachen, Germany

Campus Virchow Klinikum, Charité; 🇩🇪 Berlin, Germany

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Barzilai Medical Center, ICCU; 🇮🇱 Ashkelon, Israel

Franz-Volhard-Klinik; 🇩🇪 Berlin, Germany

Hospital Nra. Sra. de Sonsoles; 🇪🇸 Avila, Spain

Hôpital Cardiologique du Haut Lévêque; 🇫🇷 Bordeaux, France

Evangelisches Krankenhaus; 🇩🇪 Düsseldorf, Germany

Selly Oak Hospital; 🇬🇧 Birmingham, United Kingdom

Kardiologische Gemeinschaftspraxis; 🇩🇪 Hannover, Germany

Klinikum Frankfurt/Oder GmbH; 🇩🇪 Frankfurt/Oder, Germany

P. Stradina Clinical University Hospital; 🇱🇻 Riga, Latvia

VU Amsterdam; 🇳🇱 Amsterdam, Netherlands

Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo; 🇮🇹 Allessandria, Italy

Krankenhaus Bassum; 🇩🇪 Bassum, Germany

CHRU Hôpital de Villeneuve, Cardiologie B; 🇫🇷 Montpellier, France

Hôpital haut Lévêque; 🇫🇷 Pessac, France

Klinikum Coburg; 🇩🇪 Coburg, Germany

Städtisches Klinikum Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

Klinikum Johannes-Gutenberg-Universität; 🇩🇪 Mainz, Germany

Praxis Dr. Patrizia Kindler; 🇩🇪 Meiningen, Germany

Haemek Medical Center; 🇮🇱 Afula, Israel

Russels Hall Hospital; 🇬🇧 Dudley, United Kingdom

Rabin Medical Center; 🇮🇱 Petach-Tikva, Israel

CHU de Lyon - Hôpital Louis Pradel; 🇫🇷 Lyon, France

Centre Hospitalier Universitaire d'Angers; 🇫🇷 Angers, France

Centre Hospitalier; 🇫🇷 Pau, France

Groupe Hospitalier de la Timone; 🇫🇷 Marseille, France

Helios Klinikum Aue GmbH; 🇩🇪 Aue, Germany

Herzzentrum Coswig; 🇩🇪 Coswig, Germany

Good Hope; 🇬🇧 Sutton Coldfield, United Kingdom

Universitätsklinikum Charité; 🇩🇪 Berlin, Germany

Ambulantes Herzzentrum; 🇩🇪 Berlin, Germany

Vivantes Netzwerk für Gesundheit GmbH; 🇩🇪 Berlin, Germany

CHU des Rennes; 🇫🇷 Rennes, France

Swansea NHS Trust; 🇬🇧 Swansea, United Kingdom

Hadasit Medical Research Services & Development Ltd.; 🇮🇱 Jerusalem, Israel

Allgemeines Krankenhaus Altona; 🇩🇪 Hamburg, Germany

Ben Gurion University; 🇮🇱 Beer Sheva, Israel

St. Peter's Hospital / St. George's; 🇬🇧 Chertsey, United Kingdom

Zaandam Medisch Centrum; 🇳🇱 Zaandam, Netherlands

Praxisgemeinschaft; 🇩🇪 Braunschweig, Germany

Zentralkrankenhaus Links der Weser; 🇩🇪 Bremen, Germany

Carl-Thiem-Klinikum; 🇩🇪 Cottbus, Germany

Elisabeth Krankenhaus Essen; 🇩🇪 Essen, 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

Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm; 🇩🇪 Wittenberg/Lutherstadt, Germany

St. Elisabeth Klinik; 🇩🇪 Saarlouis, Germany

Städtisches Klinikum Braunschweig gGmbH; 🇩🇪 Braunschweig, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Fakultni nemocnice u Svety Anny; 🇨🇿 Brno, Czech Republic

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Gemeinschaftpraxis für Kardiologie und Angiologie; 🇩🇪 Bergisch-Gladbach, Germany

Städtische Kliniken Bielefeld gGmbH; 🇩🇪 Bielefeld, Germany

Berufsgenossenschaftliche Kliniken Bergmannsheil; 🇩🇪 Bochum, Germany

Cardiac Research GmbH; 🇩🇪 Dortmund, Germany

Praxiszentrum Herzkreislauf; 🇩🇪 Dresden, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Helios Klinikum Erfurt; 🇩🇪 Erfurt, Germany

Städtisches Klinikum St. Georg; 🇩🇪 Leipzig, Germany

Ernst-Moritz-Arndt Universität Greifswald; 🇩🇪 Greifswald, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Medizinische Universitätsklinik Homburg/Saar; 🇩🇪 Homburg/Saar, Germany

Klinikum Hoyerswerda; 🇩🇪 Hoyerswerda, Germany

Praxis Dr. med. Natour; 🇩🇪 Heidelberg, Germany

PD Dr. Christoph Karle; 🇩🇪 Künzelsau, Germany

Herzzentrum Konstanz GmbH; 🇩🇪 Konstanz, Germany

Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski; 🇩🇪 Kiel, Germany

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

Märkische Kliniken GmbH; 🇩🇪 Lüdenscheid, Germany

LKH-Universitätsklinikum Graz; 🇦🇹 Graz, Austria

IKEM; 🇨🇿 Praha, Czech Republic

Medizinische Universität Wien; 🇦🇹 Wien, Austria

Petr Neuzil M.D., Ph.D.; 🇨🇿 Praha, Czech Republic

University of Hull; 🇬🇧 Hull, United Kingdom