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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221649
• Other study ID #: JHC2
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2010
• Last updated: October 8, 2015
• Start date: June 2010
• Est. completion date: February 2014

Study information

• Verified date: February 2012
• Source: Biotronik Japan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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. 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.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Heart Failure

Intervention

Device:
• ICD/CRT-D
BIOTRONIK ICD family Lumax 540 and its successors

Locations

Country	Name	City	State
Japan	Hiroshima Shimin Hospital	Hiroshima
Japan	Yamada Red Cross Hospital	Ise	Mie
Japan	Kokura Kinen Hospital	Kitakyushu	Fukuoka
Japan	Tokyo Women's Medical University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik Japan, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HF Events	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	No