N/A N=20 Screening

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

Heart Failure · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01568606 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Number of Participants With Arrhythmia as Detected by ICD — 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Body Composition Analysis InBody Scale (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Arrhythmia as Detected by ICD	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01568606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.