Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-03-02 @ 8:16 AM
Study NCT ID:
NCT01568606
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2011-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thorwich@mednet.ucla.edu', 'phone': '310-825-8816', 'title': 'Tamara Horwich, MD, MS', 'organization': 'Ahmanson-UCLA Cardiomyopathy Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Due to small sample, we cannot exclude rare BIA-ICD interactions. Results may not be generalizable to other devices or BIA systems that utilize different frequencies.'}}, 'adverseEventsModule': {'timeFrame': '1 day, on day of study ICD interrogated and continually monitored before, during, and after 30-50 seconds of bioimpedance analysis', 'eventGroups': [{'id': 'EG000', 'title': 'Body Composition Analysis InBody Scale', 'description': 'Subjects with HF and ICD had 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. Outcome measure was assessed during a one day visit. There is no further follow-up.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Arrhythmia as Detected by ICD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Body Composition Analysis InBody Scale', 'description': 'Subjects with HF and ICD had 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day, on day of study ICD interrogated and continually monitored before, during, and after 30-50 seconds of bioimpedance analysis', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Body Composition Analysis InBody Scale', 'description': 'Subjects with HF and ICD had 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. Outcome measure was assessed during a one day visit. There is no further follow-up.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Body Composition Analysis InBody Scale', 'description': 'Subjects with HF and ICD had 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. Outcome measure was assessed during a one day visit. There is no further follow-up.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2011-08-15', 'resultsFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-02', 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Arrhythmia as Detected by ICD', 'timeFrame': '1 day, on day of study ICD interrogated and continually monitored before, during, and after 30-50 seconds of bioimpedance analysis', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Obesity', 'Implantable Cardioverter Defibrillator'], 'conditions': ['Heart Failure', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '22452409', 'type': 'RESULT', 'citation': 'Buch E, Bradfield J, Larson T, Horwich T. Effect of bioimpedance body composition analysis on function of implanted cardiac devices. Pacing Clin Electrophysiol. 2012 Jun;35(6):681-4. doi: 10.1111/j.1540-8159.2012.03377.x. Epub 2012 Mar 27.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nAlthough 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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HF patients of any etiology who currently have an implanted ICD\n\nExclusion Criteria:\n\n* patients who are non-ambulatory\n* have a physical disability making them unable to stand on the InBody\n* those who are above the height and weight maximums for the device \\[Height \\> 220cm (7'2.6''), Weight \\> 250kg (551lb)\\]\n* those who are pregnant"}, 'identificationModule': {'nctId': 'NCT01568606', 'briefTitle': 'Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Safety of Body Composition Analysis Using Bioimpedance in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)', 'orgStudyIdInfo': {'id': 'UCLA M-IRB1 # 10-001055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Body Composition Analysis InBody Scale', 'interventionNames': ['Device: Body Composition Analysis InBody Scale']}], 'interventions': [{'name': 'Body Composition Analysis InBody Scale', 'type': 'DEVICE', 'otherNames': ['Body Composition Analysis InBody 520 Scale'], 'description': '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.', 'armGroupLabels': ['Body Composition Analysis InBody Scale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ahmanson-UCLA Cardiomyopathy Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Tamara Horwich, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Tamara Horwich, M.D., M.S.', 'investigatorFullName': 'Tamara Horwich', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}