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NCT01568606 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of California, Los Angeles.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT01568606: Completed NA study, sponsored by University of California, Los Angeles.

NCT01568606 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01568606, a NA study, has completed, sponsored by University of California, Los Angeles.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DEVICE Body Composition Analysis InBody Scale

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-01
Est. Completion 2011-03
Phase NA

What the finished NCT01568606 record still lists

NCT01568606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Body Composition Analysis InBody Scale is the first listed.

NCT01568606 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01568606 about?

NCT01568606 is a clinical study titled "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 m...

What is the current status of trial NCT01568606?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2011-01. Estimated completion is 2011-03.

What interventions are being tested in trial NCT01568606?

The interventions under investigation include: Body Composition Analysis InBody Scale (DEVICE).

Who is sponsoring clinical trial NCT01568606?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01568606's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01568606, the US trial registry maintained by the National Library of Medicine. NCT01568606 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.