Clinical trial NCT00711360: Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II)
Official title: Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Arrhythmias, Cardiac
Keywords: heart failure
implantable cardioverter-defibrillator
intrathoracic impedance
cardiac resynchronization therapy
home monitoring
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Eligibility criteria: 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
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.
timeFrame: Study will last until 35 heart failure events are collected
Secondary outcomes:
measure: Further improvement of the Heart Failure Monitor based on collected data
timeFrame: The same as for primary outcome measure
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Medizinische Klinik I Aachen
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH Bad Nauheim
city: Bad Neustadt a. d. Saale
country: Germany
facility: Herz- und Gefäss-Klinik GmbH Bad Neustadt
city: Bad Oeynhausen
country: Germany
facility: HDZ Bad Oeynhausen NRW
city: Berlin
country: Germany
facility: Universitätsklinikum Benjamin Franklin
city: Bochum
country: Germany
facility: Berufsgenossenschaftliche Kliniken Bergmannsheil Universität Bochum
city: Breitenbrunn
country: Germany
facility: Kliniken Erlabrunn gGmbH
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt Universität Greifswald
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg - Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Medizinische Universitätsklinik Heidelberg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Neuss
country: Germany
facility: Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
city: Osnabrück
country: Germany
facility: Marienhospital Osnabrück GmbH
city: Papenburg
country: Germany
facility: Marienkrankenhaus Papenburg-Aschendorf GmbH
city: Saarlouis
country: Germany
facility: St. Elisabeth Klinik Saarlouis
city: Speyer
country: Germany
facility: Krankenhaus der Evangelischen Diakonissenanstalt
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Villingen
country: Germany
facility: Kliniken Villingen
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Burgos
country: Spain
facility: Hospital General Yagüe
city: Donostia - San Sebastian
country: Spain
facility: Hospital de Donostia
city: Valencia
country: Spain
facility: Hospital General universitario Valencia
city: Lugano
country: Switzerland
facility: Cardio Centro Ticino
Study officials:
affiliation: Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany
name: Sebastian Maier, PD Dr. med.
role: STUDY_CHAIR
References:
citation: 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.