Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-29 @ 8:21 AM
Study NCT ID:
NCT01428557
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2011-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BREATHE Registry - I Brazilian Registry of Heart Failure
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3013}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2011-09-01', 'studyFirstSubmitQcDate': '2011-09-02', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total mortality', 'timeFrame': 'follow up at 3, 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients receiving interventions with proven benefit shown by different indicators of quality of care.', 'timeFrame': 'follow up at 3, 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Epidemiology', 'Evidence-Based Practice'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions.', 'detailedDescription': 'Background: Several local registries seek to show an isolated clinical characteristics of patients hospitalized with heart failure (HF) in hospitals and communities in Brazil. Overall, the analysis of these data suggests that there are important differences in etiology, the factors of decompensation, treatment and prognosis of HF patients in different regions.\n\nObjectives: To evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions. Other specific objectives include describing the in-hospital mortality after admission, to describe the content and the reason for re-admission, to assess adherence to evidence-based guidelines (recommended by guidelines), to measure indicators of quality of care and establish a national registry data to allow for comparison with international records of patients admitted with ADHF.\n\nMethods: Observational cross (record) with longitudinal follow-up where patients admitted to public and private hospitals primarily defined in IC will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Public and Private Hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years old,\n* Boston Criteria \\> 7,\n* patients hospitalized \\> 24 hours.\n\nExclusion Criteria:\n\n* myocardial revascularization during last month,\n* heart failure due to sepsis,\n* acute coronary syndrome with ventricular dysfunction as reason for current hospitalization'}, 'identificationModule': {'nctId': 'NCT01428557', 'acronym': 'BREATHE', 'briefTitle': 'BREATHE Registry - I Brazilian Registry of Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': 'BREATHE Registry - I Brazilian Registry of Heart Failure', 'orgStudyIdInfo': {'id': '003/2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart Failure patients (Breathe I)', 'description': 'Patients admitted with clinical diagnosis of decompensate heart failure, \\> 18 years old.'}, {'label': 'Heart Failure patients (Breathe Extension)', 'description': 'Patients admitted with clinical diagnosis of decompensate heart failure, \\> 18 years old.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04005-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Coracao', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brazilian Society of Cardiology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}