Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-01 @ 9:19 AM
Study NCT ID:
NCT02105805
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2014-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Loss as Treatment in Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2014-03-28', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in six minute walk test from baseline to week 16 (end of study)', 'timeFrame': 'weeks 0 and 16', 'description': 'Performance measure'}], 'secondaryOutcomes': [{'measure': 'Change in lipid status from baseline to week 16 (end of study).', 'timeFrame': 'weeks 0,1,2,4,6,8,10,12,14,16', 'description': 'Blood sample and analyses for lipids'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intention weight loss', 'heart failure', '6-minute walk test'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects.\n\nAll will receive dietetic advice according to randomization and according to the European Heart Association.\n\nIntervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement.\n\nControl subjects are advised to follow the Nordic Nutrition Recommendations.\n\nPatients will be monitored by blood sampling and assessed by change in physical performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bmi \\>30\n* heart failure, moderate to severe, new york heart association II og III\n* stable disease\n* age \\>18 years\n* out-patients\n* perform a six minutes walk test\n* given consent\n\nExclusion Criteria:\n\n* unstable disease\n* insulin treated diabetes\n* pregnancy or lactating\n* unstable weight past 6 months (+- 10 kg)\n* planned procedures in the time of intervention'}, 'identificationModule': {'nctId': 'NCT02105805', 'briefTitle': 'Weight Loss as Treatment in Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease', 'orgStudyIdInfo': {'id': 'GEN-01-clinnutr'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low energy diet', 'description': 'low energy diet treatment', 'interventionNames': ['Behavioral: Dietetic group sessions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nordic recommendation', 'description': 'Nordic recommendation, no restrictions on energy', 'interventionNames': ['Behavioral: Dietetic group sessions']}], 'interventions': [{'name': 'Dietetic group sessions', 'type': 'BEHAVIORAL', 'description': 'Group sessions to improve dietary adherence', 'armGroupLabels': ['Nordic recommendation', 'low energy diet']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Arne Astrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}