Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
Study NCT ID:
NCT04332692
Status:
RECRUITING
Last Update Posted:
2023-06-05
First Post:
2020-03-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Heart Failure - COngestion Discharge Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2028-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of all-cause death', 'timeFrame': '3 months after hospital discharge', 'description': 'composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 2 and 3)'}, {'measure': 'Rate of re-hospitalisation for acute heart failure', 'timeFrame': '3 months after hospital discharge', 'description': 'composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 3)'}, {'measure': 'Rate of day-hospital or in-home IV diuretics injection for acute HF', 'timeFrame': '3 months after hospital discharge', 'description': 'composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 2)'}], 'secondaryOutcomes': [{'measure': 'Rate of all-cause death', 'timeFrame': '3, 12 and 24 months after hospital discharge'}, {'measure': 'Rate of re-hospitalisation for acute heart failure', 'timeFrame': '3,12 and 24 months after hospital discharge'}, {'measure': 'Rate of day-hospital or in-home IV diuretics injection for acute HF', 'timeFrame': '3,12 and 24 months after hospital discharge'}, {'measure': 'Rate of all-cause death', 'timeFrame': '12 and 24 months after hospital discharge', 'description': 'composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 8 and 9)'}, {'measure': 'Rate of re-hospitalisation for acute heart failure', 'timeFrame': '12 and 24 months after hospital discharge', 'description': 'composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 7 and 9)'}, {'measure': 'Rate of day-hospital or in-home IV diuretics injection for acute HF', 'timeFrame': '12 and 24 months after hospital discharge.', 'description': 'composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 7 and 8)'}, {'measure': 'Rate of all-cause death', 'timeFrame': '3, 12 and 24 months after hospital discharge.', 'description': 'composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 11 and 12)'}, {'measure': 'Rate of hospitalization for acute heart failure', 'timeFrame': '3, 12 and 24 months after hospital discharge.', 'description': 'composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 10 and 12)'}, {'measure': 'Rate of day-hospital or in-home IV diuretics injection for acute HF', 'timeFrame': '3, 12 and 24 months after hospital discharge.', 'description': 'composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 10 and 11)'}, {'measure': 'NYHA (New York Heart Association) class measured', 'timeFrame': '3, 12 and 24 months after hospital discharge'}, {'measure': 'Natriuretic peptides', 'timeFrame': 'within 24 months after hospital discharge.', 'description': 'BNP or Nt-Pro BNP'}, {'measure': 'Renal function assessed by glomerular filtration rate', 'timeFrame': 'within 24 months after hospital discharge.'}, {'measure': 'Plasma volume', 'timeFrame': 'within 24 months after hospital discharge.', 'description': 'calculated from haemoglobin and haematocrit value'}, {'measure': 'Liver elastography value', 'timeFrame': 'At inclusion', 'description': 'Measured with Fibroscan'}, {'measure': 'Quality of life', 'timeFrame': 'At inclusion and 3, 6 and 24 months', 'description': 'Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Heart Failure'], 'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound .\n\nAdapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical. The best multimodality approach to congestion evaluation is uncertain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalised for acute heart failure.\n* Patients considered clinically discharging from hospitalisation for acute heart failure.\n* Age ≥18 years\n* Patients having received complete information regarding the study design and having signed their informed consent form.\n* Patient affiliated to or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* Comorbidity for which the life expectancy is ≤ 3 months\n* Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \\<15 ml/min/m2 at inclusion.\n* History of lobectomy or pneumonectomy lung surgery\n* Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.\n* Pregnant woman, parturient or nursing mother\n* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)\n* Adult person who is unable to give consent\n* Person deprived of liberty by a judicial or administrative decision,\n* Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.'}, 'identificationModule': {'nctId': 'NCT04332692', 'acronym': 'AHF-CODE', 'briefTitle': 'Acute Heart Failure - COngestion Discharge Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': "Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.", 'orgStudyIdInfo': {'id': '2019-A03311-56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients hospitalized for acute heart failure', 'description': 'Patients hospitalized for acute heart failure will undergo the following evaluations:\n\n* Clinical examination focusing on congestion\n* Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds\n* Blood sample retrieved for biological assessment and biobanking\n* Telephone follow-up', 'interventionNames': ['Procedure: Clinical examination centered on congestion', 'Procedure: Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography', 'Procedure: Blood sample retrieved for biological assessment and biobanking', 'Procedure: Telephone follow-up', 'Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)']}], 'interventions': [{'name': 'Clinical examination centered on congestion', 'type': 'PROCEDURE', 'description': 'Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital', 'armGroupLabels': ['Patients hospitalized for acute heart failure']}, {'name': 'Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography', 'type': 'PROCEDURE', 'description': 'Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital', 'armGroupLabels': ['Patients hospitalized for acute heart failure']}, {'name': 'Blood sample retrieved for biological assessment and biobanking', 'type': 'PROCEDURE', 'description': 'Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital', 'armGroupLabels': ['Patients hospitalized for acute heart failure']}, {'name': 'Telephone follow-up', 'type': 'PROCEDURE', 'description': 'Telephone follow-up will be performed 3, 12 and 24 months after discharge from hospital', 'armGroupLabels': ['Patients hospitalized for acute heart failure']}, {'name': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'type': 'BEHAVIORAL', 'description': "Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge", 'armGroupLabels': ['Patients hospitalized for acute heart failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas GIRERD, MD, PhD', 'role': 'CONTACT', 'email': 'n.girerd@chru-nancy.fr', 'phone': '+33383157322', 'phoneExt': '+333'}], 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Nicolas GIRERD, MD,PhD', 'role': 'CONTACT', 'email': 'n.girerd@chru-nancy.fr', 'phone': '+ 33 3 83 15 73 22', 'phoneExt': '+ 33 3'}, {'name': 'Sanae BOUALI, PhD', 'role': 'CONTACT', 'email': 's.bouali@chru-nancy.fr', 'phone': '+ 33 3 83 15 73 22', 'phoneExt': '+ 33 3'}], 'overallOfficials': [{'name': 'Nicolas GIRERD, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU of Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pr. Nicolas GIRERD', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}