Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
NCT ID: NCT00538356
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
720 participants
INTERVENTIONAL
2007-07-31
2013-08-31
Brief Summary
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To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fraction receiving an implantable cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed.
Detailed Description
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The Home Monitoring™ capability offered by many BIOTRONIK implants has the potential to detect some of these trends early. During Home Monitoring surveillance, medical and technical data from an ICD or CRT device are sent to a modified mobile phone, the so-called Cardio Messenger. This device transmits the data via a mobile phone network to the BIOTRONIK service center. There, the data are put into an easily accessible form and can then be viewed by the physician online via the internet on a secure website. Additionally, the occurrence of heart rhythm disturbances or device problems will be transmitted by fax, SMS or email.
This unique system allows the attending physician to monitor each patient very closely and to react early enough to prevent worsening of heart failure at an early stage, to optimize therapy, and to secure the correct functioning of the implant.
The goal of IN-TIME is thus to analyze the impact of a regular Home Monitoring evaluation on the health status of heart failure patients receiving such an implant as part of their therapy.
A total of 720 patients with heart failure symptoms and a severely reduced pumping function receiving an ICD or a CRT-D device from up to 50 European clinical centers will be enrolled into the study. About 4 weeks after discharge from the implanting hospital, patients will be randomly assigned to prospective patient management by Home Monitoring or standard care groups. Patients in the Home Monitoring group will be monitored at least once per week, patients in the control group will not be monitored during the study, but their transmitted Home Monitoring data will be analyzed after their ending of participation in the study.
The health status of patients will be measured using the well established "Packer Score". This score is a combined measurement of death rates, hospital admission rates, heart failure symptom classification and quality of life. Patients will be classified at their end of study participation as worsened, unchanged, or improved based on these parameters. To this end, the health status of participating patients will be determined regularly during further outpatient follow ups. These will take place at regular intervals due to the standard care.
Additionally, some special parameters sent to the physician via Home Monitoring will be analyzed whether they could possibly predict an imminent worsening of a patient's health - leading to an unplanned hospital visit - so that it could perhaps be prevented in the future.
Patients remain within the study for 12 months after randomization or until their participation is ended prematurely, e.g. by withdrawal of their consent, a low data transmission rate, or death.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Home Monitoring
ICD or CRT-D with Home Monitoring feature activated Home Monitoring data will be analyzed regularly and patients will be contacted and scheduled for additional follow-up after predefined events
ICD or CRT-D with Home Monitoring feature activated
Standard care + patient management by Home Monitoring
Control
ICD or CRT-D with Home Monitoring feature deactivated Patients will be treated as per standard of care in each participating clinic
ICD or CRT-D with Home Monitoring feature deactivated
Standard care
Interventions
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ICD or CRT-D with Home Monitoring feature deactivated
Standard care
ICD or CRT-D with Home Monitoring feature activated
Standard care + patient management by Home Monitoring
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic heart failure (≥ 3 months)
* NYHA Class II or III for 1 month prior to screening
* LVEF ≤ 35% within 3 months prior to screening
* Indication for therapy with diuretics
* Patient informed consent
Exclusion Criteria
* NYHA class I or IV
* Permanent atrial fibrillation
* Life expectancy \< 1 year
* Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis
* Severe mitral regurgitation
* Symptomatic aortic stenosis
* Tricuspid valve replacement
* Known drug or alcohol abuse
* Expected non-compliance
* Pregnancy
* Participation in another telemonitoring concept
* Participation in another study
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Gerhard Hindricks, Prof. Dr.
Role: STUDY_CHAIR
Herzzentrum Leipzig, Germany
Locations
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Sydney Adventist Hospital
Wahroonga, , Australia
Universitätsklinik für Innere Medizin
Innsbruck, , Austria
Institute of Clinical and Experimental Medicine
Prague, , Czechia
Hospital Na Homolce
Prague, , Czechia
Aalborg Hospital
Aalborg, , Denmark
Århus Universitetshospital, Skejby Sygehus
Århus N, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Odense Universitets Hospital
Odense, , Denmark
Zentralklinik Bad Berka
Bad Berka, , Germany
Herz- und Gefäßklinikum Bad Neustadt GmbH
Bad Neustadt an der Saale, , Germany
Bad Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Vivantes Klinikum Neukölln
Berlin, , Germany
Vivantes Klinikum am Urban
Berlin, , Germany
Universitätsklinikum Charité Campus Benjamin Franklin
Berlin, , Germany
Vivantes Humboldt Klinikum
Berlin, , Germany
Städtische Kliniken Bielefeld
Bielefeld, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Klinikum Coburg gGmbH
Coburg, , Germany
Klinikum Lippe-Detmold
Detmold, , Germany
Westdeutsches Herzzentrum des Universitätsklinikums Essen
Essen, , Germany
Universitätsklinikum Gießen und Marburg
Giessen, , Germany
Medizinische Hochschule
Hanover, , Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, , Germany
Klinikum St. Georg gGmbH
Leipzig, , Germany
Herzzentrum der Universität Leipzig
Leipzig, , Germany
Universitätsklinik Schleswig-Holstein
Lübeck, , Germany
St. Marienhospital Lünen GmbH
Lünen, , Germany
Klinikum Schwabing, Kardiologie
Munich - Schwabing, , Germany
Kardiologische Gemeinschaftspraxis Dr. Mühling
München, , Germany
Stiftsklinik Augustinum, Innere Medizin / Kardiologie
München, , Germany
Klinikum der Universität München Großhadern
München, , Germany
Herzzentrum München-Bogenhausen
München, , Germany
Kardiologische Gemeinschaftspraxis Dr. Predel, Dr. Heinrich
Nordhausen, , Germany
St. Vincenz Krankenhaus GmbH
Paderborn, , Germany
Klinikum Pirna GmbH
Pirna, , Germany
Barzilai Medical Center
Ashkelon, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
P. Stradins Clinical University Hospital, Latvian Centre of Cardiology
Riga, , Latvia
Countries
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References
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Arya A, Block M, Kautzner J, Lewalter T, Mortel H, Sack S, Schumacher B, Sogaard P, Taborsky M, Husser D, Hindricks G; IN-TIME investigators. Influence of Home Monitoring on the clinical status of heart failure patients: Design and rationale of the IN-TIME study. Eur J Heart Fail. 2008 Nov;10(11):1143-8. doi: 10.1016/j.ejheart.2008.08.004. Epub 2008 Sep 19.
Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M, Kautzner J, Sack S, Husser D, Piorkowski C, Sogaard P; IN-TIME study group*. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014 Aug 16;384(9943):583-590. doi: 10.1016/S0140-6736(14)61176-4.
Other Identifiers
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There is no secondary ID
Identifier Type: -
Identifier Source: secondary_id
HS042
Identifier Type: -
Identifier Source: org_study_id