Ventricular FibrillationPhase 4IN-TIMENCT00538356
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
A Phase 4 study testing ICD or CRT-D with Home Monitoring feature deactivated and ICD or CRT-D with Home Monitoring feature activated in people with Ventricular Fibrillation and Ventricular Tachycardia, run by Biotronik SE & Co. KG at 39 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Fibrillation, Ventricular Tachycardia, Congestive Heart Failure
- What is being tested?
- ICD or CRT-D with Home Monitoring feature deactivated and ICD or CRT-D with Home Monitoring feature activated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 39 sitesin 7 countries
- Study dates
- Jul 2007to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Symptomatic aortic stenosis
- Tricuspid valve replacement
- Known drug or alcohol abuse
- Expected non-compliance
- Pregnancy
- Participation in another telemonitoring concept
- Participation in another study
Trial locations and contacts
39 sites in 7 countries.
39 sites in 7 countries
Germany27 sites
Zentralklinik Bad Berka
Bad Berka, 99437
Herz- und Gefäßklinikum Bad Neustadt GmbH
Bad Neustadt an der Saale, 97616
Bad Segeberger Kliniken GmbH
Bad Segeberg, 23795
Vivantes Klinikum Neukölln
Berlin, 04129
Vivantes Klinikum am Urban
Berlin, 10967
Universitätsklinikum Charité Campus Benjamin Franklin
Berlin, 12200
Vivantes Humboldt Klinikum
Berlin, 13509
Städtische Kliniken Bielefeld
Bielefeld, 22604
Universitätsklinikum Bonn
Bonn, 53105
Klinikum Coburg gGmbH
Coburg, 96450
Klinikum Lippe-Detmold
Detmold, 32756
Westdeutsches Herzzentrum des Universitätsklinikums Essen
Essen, 45122
Universitätsklinikum Gießen und Marburg
Giessen, 35392
Medizinische Hochschule
Hanover, 30625
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421
Klinikum St. Georg gGmbH
Leipzig, 04129
Herzzentrum der Universität Leipzig
Leipzig, 04289
Universitätsklinik Schleswig-Holstein
Lübeck, 23538
St. Marienhospital Lünen GmbH
Lünen, 44534
Kardiologische Gemeinschaftspraxis Dr. Mühling
München, 80379
Stiftsklinik Augustinum, Innere Medizin / Kardiologie
München, 81375
Klinikum der Universität München Großhadern
München, 81377
Herzzentrum München-Bogenhausen
München, 81925
Klinikum Schwabing, Kardiologie
Munich - Schwabing
Kardiologische Gemeinschaftspraxis Dr. Predel, Dr. Heinrich
Nordhausen, 99734
St. Vincenz Krankenhaus GmbH
Paderborn, 33098
Klinikum Pirna GmbH
Pirna, 01796
Denmark4 sites
Aalborg Hospital
Aalborg, 9100
Århus Universitetshospital, Skejby Sygehus
Århus N, 8200
Gentofte Hospital
Hellerup, 2900
Odense Universitets Hospital
Odense, 5000
Israel3 sites
Barzilai Medical Center
Ashkelon, 78306
Rabin Medical Center
Petah Tikva, 49100
Chaim Sheba Medical Center
Tel HaShomer, 52621
Czechia2 sites
Institute of Clinical and Experimental Medicine
Prague, 14021
Hospital Na Homolce
Prague, 15030
Latvia1 site
P. Stradins Clinical University Hospital, Latvian Centre of Cardiology
Riga
About this study
Official title: IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients
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.
Read the 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.
- Being tested
- ICD or CRT-D with Home Monitoring feature deactivated, ICD or CRT-D with Home Monitoring feature activated
- Keywords
- Heart failure, Rehospitalization:, Packer composite score, Home Monitoring, Cardiac resynchronization therapy, Implantable cardioverter-defibrillator
- Medical subject headings
- Ventricular Fibrillation, Tachycardia, Ventricular, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD or CRT-D with Home Monitoring feature deactivatedDevice
Standard care
ICD or CRT-D with Home Monitoring feature activatedDevice
Also called Biotronik Home Monitoring, Home Monitoring Service Center
Standard care + patient management by Home Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Home Monitoring | Experimental | 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 Receives: Device: ICD or CRT-D with Home Monitoring feature activated |
| Control | Active comparator | ICD or CRT-D with Home Monitoring feature deactivated Patients will be treated as per standard of care in each participating clinic Receives: Device: ICD or CRT-D with Home Monitoring feature deactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score)
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventricular FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerhard Hindricks, Prof. Dr., Study chair, Herzzentrum Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538356
- Sponsor's protocol ID
- HS042
- Other IDs
- There is no secondary ID
- Acronym
- IN-TIME
- Status last verified
- Dec 2014
- First submitted
- 1 Oct 2007
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18805053Hindricks 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.
PubMed 25131977
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00538356
- Acronym / sponsor ID
- IN-TIME / HS042
- Keywords
- Heart failure, Rehospitalization:, Packer composite score, Home Monitoring, Cardiac resynchronization therapy, Implantable cardioverter-defibrillator
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Monitoring | Experimental | Device: ICD or CRT-D with Home Monitoring feature activatedICD 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 |
| Control | Active comparator | Device: ICD or CRT-D with Home Monitoring feature deactivatedICD or CRT-D with Home Monitoring feature deactivated Patients will be treated as per standard of care in each participating clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Uncontrolled hypertension
- NYHA class I or IV
- Permanent atrial fibrillation
- Life expectancy < 1 year
- Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD or CRT-D with Home Monitoring feature deactivatedStandard care | Device | Control |
| ICD or CRT-D with Home Monitoring feature activatedAlso: Biotronik Home Monitoring, Home Monitoring Service CenterStandard care + patient management by Home Monitoring | Device | Home Monitoring |
Primary outcome
Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score)
Time frame: 12 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Background: PubMed 18805053Arya 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.
- Derived from this study: PubMed 25131977Hindricks 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Hindricks, Prof. Dr. study chair
Herzzentrum Leipzig, Germany
39 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ICD or CRT-D with Home Monitoring feature deactivated and ICD or CRT-D with Home Monitoring feature activated in people with Ventricular Fibrillation and Ventricular Tachycardia, run by Biotronik SE & Co. KG at 39 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany, Denmark, Israel, Czechia, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538356, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.