Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tamara Horwich, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01568606
First received: August 15, 2011
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to define the safety of using bioimpedance for analysis of body composition in heart failure patients with ICD devices. The Biospace America InBody 520 scale, using direct segmental multifrequency bioimpedance, will be utilized to assess patients' fat mass, lean muscle mass, and edema status.

Although the Biospace America InBody 520 scale is routinely used to analyze body composition in various settings including the Ahmanson-UCLA Cardiomyopathy clinic, due to theoretical concerns of safety, bioimpedance has not been routinely used in patients with ICDs. The investigators hope that this study will allow us to routinely analyze body composition in heart failure patients with ICDs, information which can be used to help guide dietary, exercise, and medical prescriptions for the investigators heart failure patients.


Condition Intervention
Heart Failure
Obesity
Device: Body Composition Analysis InBody Scale

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Safety of Body Composition Analysis Using Bioimpedance in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Absence of arrhythmia as detected by ICD [ Time Frame: Outcome measure will be assessed continually while the patient is standing on the scale up to 50 seconds. ] [ Designated as safety issue: Yes ]
    Subjects with HF and ICD will have their ICD interrogated and continually monitored by an electrophysiologist before, during, and after the 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale. If there is any suggestion of the ICD interpreting applied frequencies as a cardiac arrhythmia, the patient will be removed from the scale and the electrophysiologist will simultaneously temporarily deactivate their ICD device to prevent discharge.


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Body Composition Analysis InBody Scale Device: Body Composition Analysis InBody Scale
Patients will have their ICD interrogated using a pacemaker Programmer specifically designed from one of the 4 pacemaker manufacturers: St. Jude, Medtronic, Guidant, and Biotronik. Depending on the type of pacemaker, interrogation can be done either wirelessly or by placing a wand over the pacemaker. The ICD will be turned to a "monitor-only" mode to disable risk of ICD shock by the supervising electrophysiologist. Patient will be asked to step on the InBody 520 scale to have their body composition analyzed. Patient will continue to have their ICD actively monitored. Analysis will take approximately 30 - 50 seconds. At the end of analysis, ICD device will be returned to default settings by supervising electrophysiologist.
Other Name: Body Composition Analysis InBody 520 Scale

Detailed Description:

Up to one half of heart failure (HF) patients are overweight and obese, as measured by body mass index (BMI). Comprehensive body composition assessment utilizing bioimpedance scales wuch as Biospace America InBody 520 scale, can give accurate measurements of fat mass, lean muscle mass, and edematous water weight. Body composition analysis is routinely used in many clinical settings, including the Ahmanson-UCLA Cardiomyopathy Center. However, bioimpedance scales are generally not used in patients with implantable cardioverter-defibrillators (ICDs), a group that represents a majority of our HF patient population. The safety of InBody 520 technology - direct segmental multifrequency (5, 100, 500 KHz) bioimpedance analysis - in patients with ICDs has not been formally evaluated. There is a theoretic concern that the ICD may misinterpret the applied currents for a cardiac arrhythmia and possibly cause a discharge from the ICD. However, there has been no documentation of any adverse events in patients with ICDs using the InBody 520 or other bioimpedance scales. Furthermore, thoracic bioimpedance analysis (BioZ ICG, 70 Khz) has been documented to be successfully utilized without adverse effects in patients with HF and ICDs. This study will define the safety of using the InBody 520 scale for analysis of body composition in patients with ICD devices. Subjects with HF and and ICD will have their ICD interrogated and continually monitored by an electrophysiologist before, during, and after the 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale. If there is any suggestion of the ICD interpreting applied frequencies as a cardiac arrhythmia, the patient will be removed from the scale and the electrophysiologist will simultaneously temporarily deactivate their ICD device to prevent discharge. Twenty subjects (from the following four ICD companies: Medtronic, St. Jude, Guidant, and Biotronik) will participate in our study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HF patients of any etiology who currently have an implanted ICD

Exclusion Criteria:

  • patients who are non-ambulatory
  • have a physical disability making them unable to stand on the InBody
  • those who are above the height and weight maximums for the device [Height > 220cm (7'2.6''), Weight > 250kg (551lb)]
  • those who are pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568606

Locations
United States, California
Ahmanson-UCLA Cardiomyopathy Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Tamara Horwich, MD, MS University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Tamara Horwich, Dr. Tamara Horwich, M.D., M.S., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01568606     History of Changes
Other Study ID Numbers: UCLA M-IRB1 # 10-001055
Study First Received: August 15, 2011
Last Updated: March 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Heart Failure
Obesity
Implantable Cardioverter Defibrillator

Additional relevant MeSH terms:
Heart Failure
Obesity
Heart Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014