Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT01834833
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2013-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2013-01-17', 'studyFirstSubmitQcDate': '2013-04-17', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'days alive out of hospital 6 months post discharge', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'rehospitalisation rate at 6 months', 'timeFrame': '6 months'}, {'measure': 'mortality at 3 and 6 months', 'timeFrame': '3 and 6 months'}, {'measure': 'number of patients receiving beta-blocker at 6 months', 'timeFrame': '6 months'}, {'measure': 'number of patients receiving a ACEI at 6 months', 'timeFrame': '6 months'}, {'measure': 'QOL at 6 months', 'timeFrame': '6 months'}, {'measure': 'autoevaluation of improvement/alteration of the patient state at 6 months', 'timeFrame': '6 months'}, {'measure': 'number of patients receiving beta-blocker at 3 months', 'timeFrame': '3 months'}, {'measure': 'number of patients receiving a ACEI at 3 months', 'timeFrame': '3 months'}, {'measure': 'QOL at 3 months', 'timeFrame': '3 months'}, {'measure': 'autoevaluation of improvement/alteration of the patient state at 3 months', 'timeFrame': '3 months'}, {'measure': 'number of patients having an optimal treatment at 6 months', 'timeFrame': '6 months'}, {'measure': 'number of patients having an optimal treatment at 3 months', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute heart failure; rehospitalisation; education; follow-up'], 'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'Evaluate the benefit of systematic appointment with a cardiologist a week after hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of hospital during 6 months', 'detailedDescription': 'Background: the risk for rehospitalisation is very high after hospitalisation for acute heart failure. Aim: evaluate the benefit of a consultation with a cardiologist, including echocardiography and education of the patient, between 7 and 15 days after discharge, in high risk patients, identified with BNP or incomplete therapy. Parallel randomised study. The main endpoint is the number of day alive out of hospital during the 6 months post discharge; statistics intention to treat comparison of the number of days alive out of hospital in the group with consultation compared with the group without consultation. Recruitment 3 years and 4 months, follow-up 6 months. Patients included have been hospitalised in hospital BICHAT 75018 Paris, France. Financing is by the ministry of health (PHRQHOS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria of inclusion :\n\n* Patient with decompensated heart failure hospitalized in the hospital BICHAT,\n* For whom is planned a return at home,\n* Valid (being able to return for a consultation to the hospital)\n* Having Nt-ProBNP of exit ≥ 3500 ng /l and/or a non optimized treatment of exit - according to the doctor who has it the responsibility,\n* Having signed the consent form by participation in the study.\n\nCriteria of not inclusion :\n\n* Age \\< 18 years,\n* Not membership in a national insurance scheme or in the Universal Health\n* Coverage (CMU)(FREE UNIVERSAL HEALTH CARE)(A patient benefiting from the Medical aid of the State (AME) cannot be included)\n* Participation to another protocol of research,\n* Not being reachable by telephone in 6 months.'}, 'identificationModule': {'nctId': 'NCT01834833', 'acronym': 'CHIC', 'briefTitle': 'Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient.', 'orgStudyIdInfo': {'id': 'P110601 - PHRQ1104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'usual care without systematic cardiology evaluation between 1 and 2 weeks'}, {'type': 'EXPERIMENTAL', 'label': 'Follow-up', 'description': 'Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary', 'interventionNames': ['Other: Follow-up']}], 'interventions': [{'name': 'Follow-up', 'type': 'OTHER', 'description': 'Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary', 'armGroupLabels': ['Follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Guillaume JONDEAU, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}