Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
Primary Purpose
Heart Failure, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body Composition Analysis InBody Scale
Sponsored by
About this trial
This is an interventional screening trial for Heart Failure focused on measuring Heart Failure, Obesity, Implantable Cardioverter Defibrillator
Eligibility 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
Sites / Locations
- Ahmanson-UCLA Cardiomyopathy Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Body Composition Analysis InBody Scale
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Arrhythmia as Detected by ICD
Subjects with HF and ICD had their ICD interrogated and continually monitored by an electrophysiologist before, during, and after 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale. Outcome measure was assessed during a one day visit. There is no further follow-up.
Secondary Outcome Measures
Full Information
NCT ID
NCT01568606
First Posted
August 15, 2011
Last Updated
March 2, 2020
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT01568606
Brief Title
Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
Official Title
Safety of Body Composition Analysis Using Bioimpedance in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Obesity
Keywords
Heart Failure, Obesity, Implantable Cardioverter Defibrillator
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body Composition Analysis InBody Scale
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Body Composition Analysis InBody Scale
Other Intervention Name(s)
Body Composition Analysis InBody 520 Scale
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Arrhythmia as Detected by ICD
Description
Subjects with HF and ICD had their ICD interrogated and continually monitored by an electrophysiologist before, during, and after 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale. Outcome measure was assessed during a one day visit. There is no further follow-up.
Time Frame
1 day, on day of study ICD interrogated and continually monitored before, during, and after 30-50 seconds of bioimpedance analysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Horwich, MD, MS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmanson-UCLA Cardiomyopathy Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22452409
Citation
Buch E, Bradfield J, Larson T, Horwich T. Effect of bioimpedance body composition analysis on function of implanted cardiac devices. Pacing Clin Electrophysiol. 2012 Jun;35(6):681-4. doi: 10.1111/j.1540-8159.2012.03377.x. Epub 2012 Mar 27.
Results Reference
result
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Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
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