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

December 19, 2014 updated by: Biotronik SE & Co. KG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
720

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Gerhard Hindricks, Prof. Dr., Herzzentrum Leipzig, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS042
  • There is no secondary ID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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