Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function (IN-TIME)
Primary Purpose
Ventricular Fibrillation, Ventricular Tachycardia, Congestive Heart Failure
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ICD or CRT-D with Home Monitoring feature deactivated
ICD or CRT-D with Home Monitoring feature activated
Sponsored by
![Biotronik SE & Co. KG](https://trials-media.s3.amazonaws.com/orgs/biotronik-se-and-co-kg.jpeg)
About this trial
This is an interventional treatment trial for Ventricular Fibrillation focused on measuring Heart failure, Rehospitalization:, Packer composite score, Home Monitoring, Cardiac resynchronization therapy, Implantable cardioverter-defibrillator
Eligibility 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
Sites / Locations
- Sydney Adventist Hospital
- Universitätsklinik für Innere Medizin
- Institute of Clinical and Experimental Medicine
- Hospital Na Homolce
- Aalborg Hospital
- Gentofte Hospital
- Odense Universitets Hospital
- Århus Universitetshospital, Skejby Sygehus
- Zentralklinik Bad Berka
- Herz- und Gefäßklinikum Bad Neustadt GmbH
- Bad Segeberger Kliniken GmbH
- Vivantes Klinikum Neukölln
- Vivantes Klinikum am Urban
- Universitätsklinikum Charité Campus Benjamin Franklin
- Vivantes Humboldt Klinikum
- Städtische Kliniken Bielefeld
- Universitätsklinikum Bonn
- Klinikum Coburg gGmbH
- Klinikum Lippe-Detmold
- Westdeutsches Herzzentrum des Universitätsklinikums Essen
- Universitätsklinikum Gießen und Marburg
- Medizinische Hochschule
- Universitätsklinikum des Saarlandes
- Klinikum St. Georg gGmbH
- Herzzentrum der Universität Leipzig
- Universitätsklinik Schleswig-Holstein
- St. Marienhospital Lünen GmbH
- Klinikum Schwabing, Kardiologie
- Kardiologische Gemeinschaftspraxis Dr. Mühling
- Stiftsklinik Augustinum, Innere Medizin / Kardiologie
- Klinikum der Universität München Großhadern
- Herzzentrum München-Bogenhausen
- Kardiologische Gemeinschaftspraxis Dr. Predel, Dr. Heinrich
- St. Vincenz Krankenhaus GmbH
- Klinikum Pirna GmbH
- Barzilai Medical Center
- Rabin Medical Center
- Chaim Sheba Medical Center
- P. Stradins Clinical University Hospital, Latvian Centre of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home Monitoring
Control
Arm Description
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 deactivated Patients will be treated as per standard of care in each participating clinic
Outcomes
Primary Outcome Measures
Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score)
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
Full Information
NCT ID
NCT00538356
First Posted
October 1, 2007
Last Updated
December 19, 2014
Sponsor
Biotronik SE & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00538356
Brief Title
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
Acronym
IN-TIME
Official Title
IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Fibrillation, Ventricular Tachycardia, Congestive Heart Failure
Keywords
Heart failure, Rehospitalization:, Packer composite score, Home Monitoring, Cardiac resynchronization therapy, Implantable cardioverter-defibrillator
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Monitoring
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
ICD or CRT-D with Home Monitoring feature deactivated Patients will be treated as per standard of care in each participating clinic
Intervention Type
Device
Intervention Name(s)
ICD or CRT-D with Home Monitoring feature deactivated
Intervention Description
Standard care
Intervention Type
Device
Intervention Name(s)
ICD or CRT-D with Home Monitoring feature activated
Other Intervention Name(s)
Biotronik Home Monitoring, Home Monitoring Service Center
Intervention Description
Standard care + patient management by Home Monitoring
Primary Outcome Measure Information:
Title
Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Hindricks, Prof. Dr.
Organizational Affiliation
Herzzentrum Leipzig, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Sydney Adventist Hospital
City
Wahroonga
ZIP/Postal Code
2076
Country
Australia
Facility Name
Universitätsklinik für Innere Medizin
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Institute of Clinical and Experimental Medicine
City
Praha
ZIP/Postal Code
14021
Country
Czech Republic
Facility Name
Hospital Na Homolce
City
Praha
ZIP/Postal Code
15030
Country
Czech Republic
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Odense Universitets Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Århus Universitetshospital, Skejby Sygehus
City
Århus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Zentralklinik Bad Berka
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Herz- und Gefäßklinikum Bad Neustadt GmbH
City
Bad Neustadt
ZIP/Postal Code
97616
Country
Germany
Facility Name
Bad Segeberger Kliniken GmbH
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Vivantes Klinikum Neukölln
City
Berlin
ZIP/Postal Code
04129
Country
Germany
Facility Name
Vivantes Klinikum am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Universitätsklinikum Charité Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Vivantes Humboldt Klinikum
City
Berlin
ZIP/Postal Code
13509
Country
Germany
Facility Name
Städtische Kliniken Bielefeld
City
Bielefeld
ZIP/Postal Code
22604
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinikum Coburg gGmbH
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Klinikum Lippe-Detmold
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Facility Name
Westdeutsches Herzzentrum des Universitätsklinikums Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Medizinische Hochschule
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinikum St. Georg gGmbH
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
Herzzentrum der Universität Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Universitätsklinik Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
St. Marienhospital Lünen GmbH
City
Lünen
ZIP/Postal Code
44534
Country
Germany
Facility Name
Klinikum Schwabing, Kardiologie
City
Munich - Schwabing
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis Dr. Mühling
City
München
ZIP/Postal Code
80379
Country
Germany
Facility Name
Stiftsklinik Augustinum, Innere Medizin / Kardiologie
City
München
ZIP/Postal Code
81375
Country
Germany
Facility Name
Klinikum der Universität München Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Herzzentrum München-Bogenhausen
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis Dr. Predel, Dr. Heinrich
City
Nordhausen
ZIP/Postal Code
99734
Country
Germany
Facility Name
St. Vincenz Krankenhaus GmbH
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Klinikum Pirna GmbH
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
Rabin Medical Center
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
P. Stradins Clinical University Hospital, Latvian Centre of Cardiology
City
Riga
Country
Latvia
12. IPD Sharing Statement
Citations:
PubMed Identifier
18805053
Citation
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.
Results Reference
background
PubMed Identifier
25131977
Citation
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.
Results Reference
derived
Learn more about this trial
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
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