Clinical trial NCT01568606: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Obesity
Keywords: Heart Failure
Obesity
Implantable Cardioverter Defibrillator
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Number of Participants With Arrhythmia as Detected by ICD
timeFrame: 1 day, on day of study ICD interrogated and continually monitored before, during, and after 30-50 seconds of bioimpedance analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ahmanson-UCLA Cardiomyopathy Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Tamara Horwich, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.