Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-02 @ 7:27 AM
Study NCT ID:
NCT00911703
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2009-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining When Patients Hospitalized With Acute Heart Failure Can Be Safely Sent Home (The DECIDE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 835}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-27', 'studyFirstSubmitDate': '2009-05-29', 'studyFirstSubmitQcDate': '2009-05-29', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart-failure related adverse events', 'timeFrame': 'Measured 5 days and 30 days after ED presentation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if certain findings (blood tests, symptom improvement, etc.) after acute heart failure treatment can identify a group of patients who are safe for early hospital discharge.', 'detailedDescription': 'A fundamental question faced by physicians treating acute decompensated heart failure (ADHF) is "When has treatment worked sufficiently for safe discharge, and who requires further treatment?" Patients with ADHF have a high incidence of morbidity and mortality. Current guidelines for emergency department (ED) and hospital disposition of patients with ADHF are based on limited empirical evidence. This creates clinical uncertainty regarding disposition leads to prolonged hospitalizations, higher costs and increased resource consumption. The specific aim of the study is to develop a prediction rule from readily available clinical data to help physicians identify ADHF patients eligible for safe and early discharge from the ED and hospital after treatment is initiated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the emergency department who fulfill the modified Framingham criteria and are treated for acute heart failure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfill the modified Framingham criteria\n* Have baseline data available within 1 hour of initial ED therapy\n* Have previously documented systolic dysfunction (ejection fraction less than 50%) by echocardiogram\n* Willing and able to give informed consent\n\nThe exclusion criteria are:\n\n* Patients less than 18 years of age.'}, 'identificationModule': {'nctId': 'NCT00911703', 'acronym': 'DECIDE', 'briefTitle': 'Determining When Patients Hospitalized With Acute Heart Failure Can Be Safely Sent Home (The DECIDE Study)', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Treatment Endpoints in Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': '659'}, 'secondaryIdInfos': [{'id': 'K23HL085387-06', 'link': 'https://reporter.nih.gov/quickSearch/K23HL085387-06', 'type': 'NIH'}, {'id': 'K23HL085387-01A2', 'link': 'https://reporter.nih.gov/quickSearch/K23HL085387-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute heart failure', 'description': 'Subjects with an ED diagnosis of acute decompensated heart failure .'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Sean P. Collins, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Emergency Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Abbott Point of Care', 'class': 'INDUSTRY'}, {'name': 'Inovise Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Proffesor of Emergency Medicine', 'investigatorFullName': 'Sean Collins', 'investigatorAffiliation': 'Vanderbilt University'}}}}