Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function (IN-TIME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00538356
First received: October 1, 2007
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of heart failure.

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.


Condition Intervention Phase
Ventricular Fibrillation
Ventricular Tachycardia
Congestive Heart Failure
Device: ICD or CRT-D with Home Monitoring feature deactivated
Device: ICD or CRT-D with Home Monitoring feature activated
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rehospitalizations due to worsening heart failure; Correlation of Home Monitoring values with the clinical status; Incidence and reasons for Home Monitoring based interventions; Home Monitoring workflow analysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 720
Study Start Date: July 2007
Study Completion Date: August 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Device: ICD or CRT-D with Home Monitoring feature activated
Standard care + patient management by Home Monitoring
Other Names:
  • Biotronik Home Monitoring
  • Home Monitoring Service Center
Active Comparator: Control
ICD or CRT-D with Home Monitoring feature deactivated Patients will be treated as per standard of care in each participating clinic
Device: ICD or CRT-D with Home Monitoring feature deactivated
Standard care

Detailed Description:

Hospital admissions or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as heart rhythm disturbances, daily physical activity of a patient, or mean heart rates.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for single chamber ICD, dual chamber ICD or CRT-D
  • 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:

  • Uncontrolled hypertension
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538356

  Hide Study Locations
Locations
Australia
Sydney Adventist Hospital
Wahroonga, Australia, 2076
Austria
Universitätsklinik für Innere Medizin
Innsbruck, Austria, A-6020
Czech Republic
Institute of Clinical and Experimental Medicine
Praha, Czech Republic, 14021
Hospital Na Homolce
Praha, Czech Republic, 15030
Denmark
Aalborg Hospital
Aalborg, Denmark, 9100
Gentofte Hospital
Hellerup, Denmark, 2900
Odense Universitets Hospital
Odense, Denmark, 5000
Århus Universitetshospital, Skejby Sygehus
Århus N, Denmark, 8200
Germany
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
Herz- und Gefäßklinikum Bad Neustadt GmbH
Bad Neustadt, Germany, 97616
Bad Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
Universitätsklinikum Charité Campus Benjamin Franklin
Berlin, Germany, 12200
Vivantes Humboldt Klinikum
Berlin, Germany, 13509
Vivantes Klinikum Neukölln
Berlin, Germany, 04129
Vivantes Klinikum am Urban
Berlin, Germany, 10967
Städtische Kliniken Bielefeld
Bielefeld, Germany, 22604
Universitätsklinikum Bonn
Bonn, Germany, 53105
Klinikum Coburg gGmbH
Coburg, Germany, 96450
Klinikum Lippe-Detmold
Detmold, Germany, 32756
Westdeutsches Herzzentrum des Universitätsklinikums Essen
Essen, Germany, 45122
Universitätsklinikum Gießen und Marburg
Gießen, Germany, 35392
Medizinische Hochschule
Hannover, Germany, 30625
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
Klinikum St. Georg gGmbH
Leipzig, Germany, 04129
Herzzentrum der Universität Leipzig
Leipzig, Germany, 04289
Universitätsklinik Schleswig-Holstein
Lübeck, Germany, 23538
St. Marienhospital Lünen GmbH
Lünen, Germany, 44534
Klinikum Schwabing, Kardiologie
Munich - Schwabing, Germany
Stiftsklinik Augustinum, Innere Medizin / Kardiologie
München, Germany, 81375
Herzzentrum München-Bogenhausen
München, Germany, 81925
Kardiologische Gemeinschaftspraxis Dr. Mühling
München, Germany, 80379
Klinikum der Universität München Großhadern
München, Germany, 81377
Kardiologische Gemeinschaftspraxis Dr. Predel, Dr. Heinrich
Nordhausen, Germany, 99734
St. Vincenz Krankenhaus GmbH
Paderborn, Germany, 33098
Klinikum Pirna GmbH
Pirna, Germany, 01796
Israel
Barzilai Medical Center
Ashkelon, Israel, 78306
Rabin Medical Center
Petach-Tikva, Israel, 49100
Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621
Latvia
P. Stradins Clinical University Hospital, Latvian Centre of Cardiology
Riga, Latvia
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Study Chair: Gerhard Hindricks, Prof. Dr. Herzzentrum Leipzig, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00538356     History of Changes
Other Study ID Numbers: HS042, There is no secondary ID
Study First Received: October 1, 2007
Last Updated: December 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Heart failure
Rehospitalization:
Packer composite score
Home Monitoring
Cardiac resynchronization therapy
Implantable cardioverter-defibrillator

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014