Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
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.
|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)|
- 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.
|Study Start Date:||January 2011|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568606
|United States, California|
|Ahmanson-UCLA Cardiomyopathy Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Tamara Horwich, MD, MS||University of California, Los Angeles|