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

NCT01221649 | Completed Phase 4

• 1 other identifier: JHC2
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 4

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 (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.

Conditions

Heart Failure; Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

ICD/CRT-D DEVICE

BIOTRONIK ICD family Lumax 540 and its successors

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
• 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

You may not qualify if:

• Age \< 18 years
• Contraindication for ICD implantation
• Post heart transplant (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 Japan, Inc.: lead

Study Sites (4)

Kokura Kinen Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Hiroshima Shimin Hospital

Hiroshima, Hiroshima, Japan

Location

Yamada Red Cross Hospital

Ise, Mie-ken, 516-0805, Japan

Location

Tokyo Women's Medical University

Tokyo, Tokyo, Japan

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

• Shoda Morio, DR

  Tokyo Women's University Hospital

  PRINCIPAL INVESTIGATOR

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: October 12, 2010
• First Posted: October 15, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 12, 2015

Record last verified: 2012-02

Locations

JP (4)