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

8. oktober 2015 opdateret af: Biotronik Japan, Inc.

Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement in Japan

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 (HF) 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The new BIOTRONIK 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 HF 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)

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

198

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Hiroshima, Japan
        • Hiroshima Shimin Hospital
      • Tokyo, Japan
        • Tokyo Women's Medical University
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 802-8555
        • Kokura Kinen Hospital
    • Mie
      • Ise, Mie, Japan, 516-0805
        • Yamada Red Cross Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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
  • New York Heart Association (NYHA)-class II to IV
  • Left ventricular ejection fraction (LVEF) lower or equal to 35%
  • Patient accepts Home Monitoring concept and has sufficient Global System for Mobile Communications (GSM) /General Packet Radio Service (GPRS) net coverage
  • Increased risk for HF-related hospitalization according to pre-defined criteria
  • Patient information
  • Informed consent

Exclusion Criteria:

  • Age < 18 years
  • Contraindication for ICD implantation
  • Post heart transplant (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
  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HF Events
Tidsramme: 21 months follow-up
Long-term impedance trends in patients with clinically relevant HF events, to support the development of impedance based detection algorithms. A posterior assessment of sensitivity and false alarm rate of the detection algorithms.
21 months follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biotronik Japan, Inc.

Efterforskere

  • Ledende efterforsker: Shoda Morio, DR, Tokyo Women's University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2010

Primær færdiggørelse (Faktiske)

1. februar 2014

Studieafslutning (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først indsendt

12. oktober 2010

Først indsendt, der opfyldte QC-kriterier

14. oktober 2010

Først opslået (Skøn)

15. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2015

Sidst verificeret

1. februar 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • JHC2

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsor / samarbejdspartnere

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