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

Not Applicable

Completed

• Conditions: Obesity; Heart Failure
• Interventions: Device: Body Composition Analysis InBody Scale

• Registration Number: NCT01568606
• Lead Sponsor: University of California, Los Angeles

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-02
• Results First Submitted: 2019-04-01
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-02
• Last Update Submitted: 2020-03-02
• Results First Posted: 2020-03-10
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Body Composition Analysis InBody Scale	Body Composition Analysis InBody Scale	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Arrhythmia as Detected by ICD	1 day, on day of study ICD interrogated and continually monitored before, during, and after 30-50 seconds of bioimpedance analysis	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.

Trial Locations

Locations (1)

Ahmanson-UCLA Cardiomyopathy Center; 🇺🇸 Los Angeles, California, United States