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Heart FailurePhase 4HomeCARE IINCT00711360

Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II)

A Phase 4 study testing Intrathoracic impedance measurement in people with Heart Failure and Arrhythmias, Cardiac, run by Biotronik SE & Co. KG at 28 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Arrhythmias, Cardiac
What is being tested?
Intrathoracic impedance measurement
Type of treatment
Medical device
How many people
303 participants
Where
28 sitesin 3 countries
Study dates
Jul 2008to Sep 2012
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

  • Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted with a Lumax 540 device or successor
  • NYHA-class II to IV
  • LVEF lower or equal to 35%
  • Patient accepts Home Monitoring concept and has sufficient GSM/GPRS net coverage
  • Increased risk for HF-related hospitalization according to pre-defined criteria
  • Patient information
  • Informed consent

Who cannot join

  • Age < 18 years
  • Contraindication for ICD implantation
  • Post HTX or actively listed for HTX
  • Cardiac surgery within the previous 3 months or planned at time of inclusion
  • Acute coronary syndrome within the previous 3 months
  • Chronic renal dialysis
Show all 11Show fewer
  • Pregnant or breast-feeding women
  • Limited contractual capability
  • Participation in another study
  • Anticipated non-compliance with the follow-up scheme
  • Life expectancy not longer than 1.5 years due to a non-cardiac disease

Trial locations and contacts

28 sites in 3 countries.

28 sites in 3 countries

Germany24 sites

  • RWTH Medizinische Klinik I Aachen

    Aachen

  • Klinikum Aschaffenburg

    Aschaffenburg

  • Kerckhoff-Klinik GmbH Bad Nauheim

    Bad Nauheim

  • Herz- und Gefäss-Klinik GmbH Bad Neustadt

    Bad Neustadt A. D. Saale

  • HDZ Bad Oeynhausen NRW

    Bad Oeynhausen

  • Universitätsklinikum Benjamin Franklin

    Berlin

  • Berufsgenossenschaftliche Kliniken Bergmannsheil Universität Bochum

    Bochum

  • Kliniken Erlabrunn gGmbH

    Breitenbrunn

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf

  • Universitätsklinikum Essen

    Essen

  • Ernst-Moritz-Arndt Universität Greifswald

    Greifswald

  • Asklepios Klinik St. Georg

    Hamburg

  • Universitätsklinikum Hamburg - Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Medizinische Universitätsklinik Heidelberg

    Heidelberg

  • Universitätsklinikum Jena

    Jena

  • Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH

    Neuss

  • Marienhospital Osnabrück GmbH

    Osnabrück

  • Marienkrankenhaus Papenburg-Aschendorf GmbH

    Papenburg

  • St. Elisabeth Klinik Saarlouis

    Saarlouis

  • Krankenhaus der Evangelischen Diakonissenanstalt

    Speyer

  • Universitätsklinikum Tübingen

    Tübingen

  • Kliniken Villingen

    Villingen

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

Spain3 sites

  • Hospital General Yagüe

    Burgos

  • Hospital de Donostia

    Donostia / San Sebastian

  • Hospital General universitario Valencia

    Valencia

Other trials in Spain

Switzerland1 site

  • Cardio Centro Ticino

    Lugano

Other trials in Switzerland

About this study

Official title: Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement

The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. In future, this will allow for automatic early detection of imminent decompensation at a presymptomatic stage and immediate initialization of clinical meaningful therapeutic interventions preventing heart failure related hospitalizations. The aim of this investigation is to record long-term impedance trends in heart failure patients with and without heart failure related events (hospitalizations due to acute decompensation) in order to develop algorithms for device-based early detection and warning of HF deterioration accompanied by pulmonary congestion.

Read the detailed description

The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. In future, this will allow for automatic early detection of imminent decompensation at a presymptomatic stage and immediate initialization of clinical meaningful therapeutic interventions preventing heart failure related hospitalizations. The aim of this investigation is to record long-term impedance trends in heart failure patients with and without heart failure related events (hospitalizations due to acute decompensation) in order to develop algorithms for device-based early detection and warning of HF deterioration accompanied by pulmonary congestion.

Lumax is the name of a family of implantable ICDs. The primary objective of the therapy is the prevention of sudden cardiac death. The aim is to automatically detect and terminate cardiac arrest caused by ventricular tachyarrhythmia. All major therapeutical approaches from the field of cardiology and electrophysiology are contained within the Lumax family.

Furthermore, the device is capable of treating bradycardia arrhythmias and congestive heart failure. Congestive heart failure is treated with cardiac resynchronization therapy with multisite ventricular pacing known as cardiac resynchronization therapy (CRT).

The integrated Home Monitoring component can provide information about occurring rhythm disturbances and delivered therapies close to real time as well as by intracardiac electrogram (IEGM) Online HD®. Furthermore, statistical data about the patient's condition as well as information about the integrity status of the implant itself are sent.

The implantation of an ICD is a symptomatic therapy with the following objectives:

  • Termination of spontaneous ventricular fibrillation (VF) through shock delivery
  • Termination of spontaneous ventricular tachycardia (VT) by means of antitachycardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT with shock delivery
  • Cardiac resynchronization by multisite ventricular pacing (triple-chamber implant)
  • Compensation of bradycardia through ventricular (single-chamber implant) or atrioventricular sequential pacing (dual- and triple-chamber implant)
Being tested
Intrathoracic impedance measurement
Keywords
heart failure, implantable cardioverter-defibrillator, intrathoracic impedance, cardiac resynchronization therapy, home monitoring
Medical subject headings
Heart Failure, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrathoracic impedance measurementDevice

    Intrathoracic impedance measurement by cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs) (Lumax 540)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Long-term impedance trends in patients with clinically relevant heart failure events, to support the development of impedance based detection algorithms. A posterior assessment of sensitivity and false alarm rate of the detection algorithms.

    Measured: Study will last until 35 heart failure events are collected

Secondary outcomes (1)

  1. Further improvement of the Heart Failure Monitor based on collected data

    Measured: The same as for primary outcome measure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2012
  4. Study completionSep 2012

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711360
Sponsor's protocol ID
TA083
Other IDs
There is no secondary ID
Acronym
HomeCARE II
Status last verified
Sep 2012
First submitted
7 Jul 2008
Last updated
26 Sep 2012
Results posted
No
Data monitoring committee
No

Publications

  • Maier SKG, Paule S, Jung W, Koller M, Ventura R, Quesada A, Bordachar P, Garcia-Fernandez FJ, Schumacher B, Lobitz N, Takizawa K, Ando K, Adachi K, Shoda M. Evaluation of thoracic impedance trends for implant-based remote monitoring in heart failure patients - Results from the (J-)HomeCARE-II Study. J Electrocardiol. 2019 Mar-Apr;53:100-108. doi: 10.1016/j.jelectrocard.2019.01.004. Epub 2019 Jan 25.

    PubMed 30739055

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intrathoracic impedance measurement in people with Heart Failure and Arrhythmias, Cardiac, run by Biotronik SE & Co. KG at 28 sites in 3 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 7 inclusion and 11 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 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Germany, Spain, Switzerland. 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?

Long-term impedance trends in patients with clinically relevant heart failure events, to support the development of impedance based detection algorithms. A posterior assessment of sensitivity and false alarm rate of the detection algorithms. (time frame: Study will last until 35 heart failure events are collected). 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 NCT00711360, which also lists 1 linked publication.

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 26 Sep 2012.

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