Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
Study NCT ID:
NCT05704595
Status:
WITHDRAWN
Last Update Posted:
2025-04-27
First Post:
2023-01-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000554', 'term': 'Ambulatory Care Facilities'}], 'ancestors': [{'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study no longer moving forward', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days alive and out of hospital', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Days alive and out of hospital', 'timeFrame': '90 days'}, {'measure': 'Total hospitalizations', 'timeFrame': '30 days'}, {'measure': 'Total hospitalizations', 'timeFrame': '90 days'}, {'measure': 'Total emergency department visits', 'timeFrame': '30 days'}, {'measure': 'Total emergency department visits', 'timeFrame': '90 days'}, {'measure': 'Death', 'timeFrame': '30 days'}, {'measure': 'Death', 'timeFrame': '90 days'}, {'measure': 'Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index', 'timeFrame': '30 days', 'description': 'The EQ5D utility index consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health).'}, {'measure': 'Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)', 'timeFrame': '30 days', 'description': "The EQ5D VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health."}, {'measure': 'Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index', 'timeFrame': '90 days', 'description': 'The EQ5D utility index consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health).'}, {'measure': 'Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)', 'timeFrame': '90 days', 'description': "The EQ5D VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of the OUTPATIENT-WHF study is to characterize the effectiveness of outpatient intravenous diuretic therapy as a treatment for worsening heart failure.', 'detailedDescription': 'The purpose of this study is to determine whether treating certain patients with worsening heart failure as an outpatient with intravenous and oral medications can work just as well as treating patients in the hospital.\n\nParticipants who enter into the study and meet eligibility criteria will be randomly chosen to either get intravenous diuretic like Lasix in the clinic and get outpatient care, versus directly admitted to the hospital to receive intravenous diuretic and normal hospital care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥18 years of age\n2. Presentation to a Duke outpatient clinic with heart failure requiring IV diuretics, as per clinician judgement\n3. Able to provide signed informed consent\n4. Successful completion of EuroQOL-5 dimensions survey\n\nExclusion Criteria:\n\n1. Managing clinician without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.\n2. Patient without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.\n3. History of left ventricular assist device or heart transplantation\n4. End-stage kidney disease requiring chronic dialysis therapy\n5. New diagnosis of heart failure\n6. Pregnant or breast-feeding\n7. Fever \\>101.0 degrees Fahrenheit at screening\n8. Any other condition that in the judgment of the investigator would jeopardize the patient's compliance with the study protocol"}, 'identificationModule': {'nctId': 'NCT05704595', 'briefTitle': 'Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)', 'orgStudyIdInfo': {'id': 'Pro00111091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Initial outpatient management strategy, including outpatient IV diuretics in clinic', 'interventionNames': ['Other: Initial outpatient management strategy, including outpatient IV diuretics in clinic']}, {'type': 'OTHER', 'label': 'Initial hospitalization-based management strategy', 'interventionNames': ['Other: Initial hospitalization-based management strategy']}], 'interventions': [{'name': 'Initial outpatient management strategy, including outpatient IV diuretics in clinic', 'type': 'OTHER', 'description': 'Management strategy including IV diuretic in the outpatient clinic', 'armGroupLabels': ['Initial outpatient management strategy, including outpatient IV diuretics in clinic']}, {'name': 'Initial hospitalization-based management strategy', 'type': 'OTHER', 'description': 'Direct admission to the hospital', 'armGroupLabels': ['Initial hospitalization-based management strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Stephen Greene', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}