N/A
Completed N=20
Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
Source: ClinicalTrials.gov NCT01568606 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Number of Participants With Arrhythmia as Detected by ICD — 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Arrhythmia as Detected by ICD |
— | — |
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
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. Informational only — not medical advice.