Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
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| ClinicalTrials.gov Identifier: NCT01568606 |
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Recruitment Status :
Completed
First Posted : April 2, 2012
Results First Posted : March 10, 2020
Last Update Posted : March 10, 2020
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Sponsor:
University of California, Los Angeles
Information provided by (Responsible Party):
Tamara Horwich, University of California, Los Angeles
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure Obesity | Device: Body Composition Analysis InBody Scale | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | Safety of Body Composition Analysis Using Bioimpedance in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs) |
| Study Start Date : | January 2011 |
| Actual Primary Completion Date : | March 2011 |
| Actual Study Completion Date : | March 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Body Composition Analysis InBody Scale |
Device: Body Composition Analysis InBody Scale
Patients will have their ICD interrogated using a pacemaker Programmer specifically designed from one of the 4 pacemaker manufacturers: St. Jude, Medtronic, Guidant, and Biotronik. Depending on the type of pacemaker, interrogation can be done either wirelessly or by placing a wand over the pacemaker. The ICD will be turned to a "monitor-only" mode to disable risk of ICD shock by the supervising electrophysiologist. Patient will be asked to step on the InBody 520 scale to have their body composition analyzed. Patient will continue to have their ICD actively monitored. Analysis will take approximately 30 - 50 seconds. At the end of analysis, ICD device will be returned to default settings by supervising electrophysiologist.
Other Name: Body Composition Analysis InBody 520 Scale |
Primary Outcome Measures :
- Number of Participants With Arrhythmia as Detected by ICD [ Time Frame: 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568606
Locations
| United States, California | |
| Ahmanson-UCLA Cardiomyopathy Center | |
| Los Angeles, California, United States, 90095 | |
Sponsors and Collaborators
University of California, Los Angeles
Investigators
| Principal Investigator: | Tamara Horwich, MD, MS | University of California, Los Angeles |
Publications of Results:
| Responsible Party: | Tamara Horwich, Dr. Tamara Horwich, M.D., M.S., University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01568606 |
| Other Study ID Numbers: |
UCLA M-IRB1 # 10-001055 |
| First Posted: | April 2, 2012 Key Record Dates |
| Results First Posted: | March 10, 2020 |
| Last Update Posted: | March 10, 2020 |
| Last Verified: | March 2020 |
Keywords provided by Tamara Horwich, University of California, Los Angeles:
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Heart Failure Obesity Implantable Cardioverter Defibrillator |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |