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

NCT00711360 | Completed Phase 4

• 2 other identifiers: TA083There is no secondary ID
• Study Type: interventional
• Target: 303
• Locations: 3 countries
• Sites: 28

Brief 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. 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.

Conditions

Heart Failure; Arrhythmias, Cardiac

Keywords

heart failure; implantable cardioverter-defibrillator; intrathoracic impedance; cardiac resynchronization therapy; home monitoring

Outcome Measures

Primary Outcomes (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.

  Study will last until 35 heart failure events are collected

Secondary Outcomes (1)

• Further improvement of the Heart Failure Monitor based on collected data

  The same as for primary outcome measure

Interventions

Intrathoracic impedance measurement DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Contraindication for ICD implantation
• Post HTX or actively listed for HTX
• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (28)

RWTH Medizinische Klinik I Aachen

Aachen, Germany

Location

Klinikum Aschaffenburg

Aschaffenburg, Germany

Location

Kerckhoff-Klinik GmbH Bad Nauheim

Bad Nauheim, Germany

Location

Herz- und Gefäss-Klinik GmbH Bad Neustadt

Bad Neustadt A. D. Saale, Germany

Location

HDZ Bad Oeynhausen NRW

Bad Oeynhausen, Germany

Location

Universitätsklinikum Benjamin Franklin

Berlin, Germany

Location

Berufsgenossenschaftliche Kliniken Bergmannsheil Universität Bochum

Bochum, Germany

Location

Kliniken Erlabrunn gGmbH

Breitenbrunn, Germany

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Ernst-Moritz-Arndt Universität Greifswald

Greifswald, Germany

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Universitätsklinikum Hamburg - Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Medizinische Universitätsklinik Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH

Neuss, Germany

Location

Marienhospital Osnabrück GmbH

Osnabrück, Germany

Location

Marienkrankenhaus Papenburg-Aschendorf GmbH

Papenburg, Germany

Location

St. Elisabeth Klinik Saarlouis

Saarlouis, Germany

Location

Krankenhaus der Evangelischen Diakonissenanstalt

Speyer, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Kliniken Villingen

Villingen, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

Hospital General Yagüe

Burgos, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, Spain

Location

Hospital General universitario Valencia

Valencia, Spain

Location

Cardio Centro Ticino

Lugano, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 30739055 DERIVED

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastian Maier, PD Dr. med.

  Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 8, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

CH (1); ES (3); DE (24)