Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT00776035
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2008-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sex and Obesity: Effects on Heart Failure Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'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'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D059552', 'term': 'Caves'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055593', 'term': 'Geological Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lpeterso@wustl.edu', 'phone': '314-362-4577', 'title': 'Linda R. Peterson, MD, Professor of Medicine and Radiology', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and treatment-emergent adverse events were collected from Study Day 1 to 48 hours after Study Day 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Men With Heart Failure', 'description': 'Men with obesity-related heart failure', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Women With Heart Failure', 'description': 'Women with obesity-related heart failure', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Myocardial Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Men With Heart Failure', 'description': 'Men with obesity-related heart failure'}, {'id': 'OG001', 'title': 'Women With Heart Failure', 'description': 'Women with obesity-related heart failure'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.005', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Average myocardial blood flow, men versus women', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 2', 'description': 'Myocardial blood flow (MBF) was measured using \\^15O-water injected intravenously intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.', 'unitOfMeasure': 'mL/g/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the PET scan assessment'}, {'type': 'SECONDARY', 'title': 'Average Myocardial Fatty Acid Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Men With Heart Failure', 'description': 'Men with obesity-related heart failure'}, {'id': 'OG001', 'title': 'Women With Heart Failure', 'description': 'Women with obesity-related heart failure'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '26', 'groupId': 'OG000'}, {'value': '139', 'spread': '68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Average myocardial fatty acid utilization, men versus women', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 2', 'description': 'Myocardial fatty acid (FA) utilization was measured using 1-\\^11C-palmitate injected intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.', 'unitOfMeasure': 'nmol/g/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the PET assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Men With Heart Failure', 'description': 'Men with obesity-related heart failure'}, {'id': 'FG001', 'title': 'Women With Heart Failure', 'description': 'Women with obesity-related heart failure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants with nonischemic heart failure'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Men With Heart Failure', 'description': 'Men with obesity-related heart failure'}, {'id': 'BG001', 'title': 'Women With Heart Failure', 'description': 'Women with obesity-related heart failure'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '3', 'groupId': 'BG000'}, {'value': '41', 'spread': '3', 'groupId': 'BG001'}, {'value': '41.5', 'spread': '9.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Homeostasis model assessment of insulin resistance', 'classes': [{'categories': [{'measurements': [{'value': '2.55', 'spread': '0.51', 'groupId': 'BG000'}, {'value': '4.40', 'spread': '1.77', 'groupId': 'BG001'}, {'value': '3.52', 'spread': '4.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HOMA-IR is a method to estimate insulin resistance. It is calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. A score of \\<1 indicates insulin-sensitivity; \\>1.9 indicates early insulin resistance; and \\>2.9 indicates significant insulin resistance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '2', 'groupId': 'BG000'}, {'value': '35', 'spread': '8', 'groupId': 'BG001'}, {'value': '32.96', 'spread': '7.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index (BMI) is a measure of body fat based on height and weight. It is calculated as body weight divided by the square of body height. Underweight = \\<18.5; normal weight = 18.5 to 24.9; overweight = 25 to 29.9; and obesity is \\>30.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participants with nonischemic heart failure'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Non diagnostic genetic samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2011-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2008-10-17', 'resultsFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2008-10-17', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-09', 'studyFirstPostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Myocardial Blood Flow', 'timeFrame': 'Study Day 2', 'description': 'Myocardial blood flow (MBF) was measured using \\^15O-water injected intravenously intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.'}], 'secondaryOutcomes': [{'measure': 'Average Myocardial Fatty Acid Utilization', 'timeFrame': 'Study Day 2', 'description': 'Myocardial fatty acid (FA) utilization was measured using 1-\\^11C-palmitate injected intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Heart', 'Failure', 'PET (positron emission tomography)', 'radiation', 'metabolism'], 'conditions': ['Obesity', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '15474689', 'type': 'BACKGROUND', 'citation': 'Essop MF, Opie LH. Metabolic therapy for heart failure. Eur Heart J. 2004 Oct;25(20):1765-8. doi: 10.1016/j.ehj.2004.08.019. No abstract available.'}, {'pmid': '15527683', 'type': 'BACKGROUND', 'citation': 'Taegtmeyer H, Salazar R. Myocardial metabolism: a new target for the treatment of heart disease? Curr Hypertens Rep. 2004 Dec;6(6):414-5. doi: 10.1007/s11906-004-0033-5. No abstract available.'}, {'pmid': '15987803', 'type': 'BACKGROUND', 'citation': 'Stanley WC, Recchia FA, Lopaschuk GD. Myocardial substrate metabolism in the normal and failing heart. Physiol Rev. 2005 Jul;85(3):1093-129. doi: 10.1152/physrev.00006.2004.'}, {'pmid': '12151467', 'type': 'BACKGROUND', 'citation': 'Kenchaiah S, Evans JC, Levy D, Wilson PW, Benjamin EJ, Larson MG, Kannel WB, Vasan RS. Obesity and the risk of heart failure. N Engl J Med. 2002 Aug 1;347(5):305-13. doi: 10.1056/NEJMoa020245.'}, {'pmid': '15123530', 'type': 'BACKGROUND', 'citation': 'Peterson LR, Herrero P, Schechtman KB, Racette SB, Waggoner AD, Kisrieva-Ware Z, Dence C, Klein S, Marsala J, Meyer T, Gropler RJ. Effect of obesity and insulin resistance on myocardial substrate metabolism and efficiency in young women. Circulation. 2004 May 11;109(18):2191-6. doi: 10.1161/01.CIR.0000127959.28627.F8. Epub 2004 May 3.'}, {'pmid': '12535825', 'type': 'BACKGROUND', 'citation': 'Kates AM, Herrero P, Dence C, Soto P, Srinivasan M, Delano DG, Ehsani A, Gropler RJ. Impact of aging on substrate metabolism by the human heart. J Am Coll Cardiol. 2003 Jan 15;41(2):293-9. doi: 10.1016/s0735-1097(02)02714-6.'}, {'pmid': '17679067', 'type': 'BACKGROUND', 'citation': 'Peterson LR, Soto PF, Herrero P, Schechtman KB, Dence C, Gropler RJ. Sex differences in myocardial oxygen and glucose metabolism. J Nucl Cardiol. 2007 Jul;14(4):573-81. doi: 10.1016/j.nuclcard.2007.03.001. Epub 2007 Jun 27.'}, {'pmid': '12106931', 'type': 'BACKGROUND', 'citation': 'Davila-Roman VG, Vedala G, Herrero P, de las Fuentes L, Rogers JG, Kelly DP, Gropler RJ. Altered myocardial fatty acid and glucose metabolism in idiopathic dilated cardiomyopathy. J Am Coll Cardiol. 2002 Jul 17;40(2):271-7. doi: 10.1016/s0735-1097(02)01967-8.'}]}, 'descriptionModule': {'briefSummary': "Sex has a major impact on myocardial metabolism and blood flow. In those without heart failure men's hearts tend to use proportionally more glucose and women's hearts use more fat and have higher blood flow.\n\nObesity is a major risk factor for Heart Failure. In those without heart failure, increasing body mass index is predictive of increased blood flow and fatty acid metabolism in women, but not men.\n\nTo measure blood flow and metabolism we used radioactive materials and a PET (positron emission Tomography) scan to study the blood flow and substrate metabolism of the heart.\n\nHypotheses: 1) Women with heart failure with reduced ejection fraction (HFrEF) will have higher levels of heart blood flow and fatty acid metabolism and lower glucose metabolism rates than men with HFrEF. A secondary Aim was to test the hypothesis that body mass index (BMI), a measure of obesity, correlated with myocardial blood flow and myocardial metabolism measures in patients with HFrEF."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with heart failure were recruited for this study from the Washington University in St. Louis VO2 peak database, which consisted of participants who had been referred to and completed VO2 testing in the Cardiac Rehabilitation-run laboratory since 1998.', 'genderDescription': 'Males and females assigned so at birth are eligible to participate. Since the purpose was to evaluate sex-related differences in blood flow and metabolism without the effects of exogenous hormones, those taking the latter were excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Heart failure (HF) and a systolic ejection fraction \\<45% per a recent echocardiogram report)\n* Nonischemic HF New York Heart Association Class II-III\n* Ambulatory\n* Able to give informed consent\n* On a stable medical regimen including the standard-of-care HF medications (i.e., a beta-blocker, ACE-inhibitor or angiotensin receptor blocker \\[ARB\\])\n\nExclusion criteria\n\n* Participants who were pregnant or lactating\n* Actively losing weight\n* Nonsedentary (performing aerobic exercise \\> 30 minutes x 3 times/week)\n* Those who have more than Class I hypertension\n* Those who require alterations in beta-blocker or ACE or ARB-inhibition medication\n* Those with hypertrophic, constrictive, or restrictive cardiomyopathies\n* Those unable to lie flat in the PET scanner\n* Severe major organ system dysfunction (other than heart failure)\n* Significant coronary artery disease by catheterization\n* Those unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT00776035', 'briefTitle': 'Sex and Obesity: Effects on Heart Failure Study', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Sex and Obesity Effects on Myocardial Blood Flow and Metabolism', 'orgStudyIdInfo': {'id': '07-1128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Men with heart failure', 'description': 'Men with obesity-related heart failure', 'interventionNames': ['Procedure: PET (Positron Emission Tomography)', 'Procedure: Echocardiogram', 'Radiation: ^15O-water', 'Radiation: 1-^11C-palmitate', 'Radiation: 1-^11C-glucose']}, {'label': 'Women with heart failure', 'description': 'Women with obesity-related heart failure', 'interventionNames': ['Procedure: PET (Positron Emission Tomography)', 'Procedure: Echocardiogram', 'Radiation: ^15O-water', 'Radiation: 1-^11C-palmitate', 'Radiation: 1-^11C-glucose']}], 'interventions': [{'name': 'PET (Positron Emission Tomography)', 'type': 'PROCEDURE', 'otherNames': ['PET scan'], 'description': 'This is a diagnostic scan that requires the injection of radioactive tracer compounds intravenously using an IV placed in the arm.', 'armGroupLabels': ['Men with heart failure', 'Women with heart failure']}, {'name': 'Echocardiogram', 'type': 'PROCEDURE', 'otherNames': ['Echo'], 'description': 'An echocardiogram is an ultrasound of the heart. Participants received a complete 2D- and Doppler echocardiographic examination on the day of the PET scan.', 'armGroupLabels': ['Men with heart failure', 'Women with heart failure']}, {'name': '^15O-water', 'type': 'RADIATION', 'description': 'This is a radioactive tracer used to study blood flow in the heart during the PET scan. It was administered intravenously at a dose of 20 mCi.', 'armGroupLabels': ['Men with heart failure', 'Women with heart failure']}, {'name': '1-^11C-palmitate', 'type': 'RADIATION', 'description': 'This is a radioactive tracer used to study fatty acid usage in the heart during the PET scan. It was administered intravenously at a dose of 20 mCi.', 'armGroupLabels': ['Men with heart failure', 'Women with heart failure']}, {'name': '1-^11C-glucose', 'type': 'RADIATION', 'description': 'This is a radioactive tracer used to study glucose usage in the heart during the PET scan. It was administered intravenously at a dose of 20 Mci..', 'armGroupLabels': ['Men with heart failure', 'Women with heart failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Linda Peterson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Foundation for Barnes-Jewish Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}