Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-03-09 @ 4:38 PM
Study NCT ID:
NCT03056651
Status:
UNKNOWN
Last Update Posted:
2020-05-27
First Post:
2017-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Day-care Unit for Patients With Refractory Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-25', 'studyFirstSubmitDate': '2017-02-12', 'studyFirstSubmitQcDate': '2017-02-14', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with rehospitalization due to heart failure decompensation', 'timeFrame': 'From date of inclusion until the date of death from any cause, assessed up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Number of participants with major adverse cardiovascular event', 'timeFrame': 'From date of inclusion until the date of death from any cause, assessed up to 1 year'}, {'measure': 'Number of participants with reported deaths from any cause', 'timeFrame': 'From date of inclusion until the date of death from any cause, assessed up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'day care', 'prognosis'], 'conditions': ['Heart Failure', 'Heart Diseases', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is an observational study on selected patients with advanced refractory heart failure. The purpose of the study was to examine the comprehensive management of HF in the day-care unit in terms of the safety and its impact on the rehospitalization and mortality rates in patients with advanced refractory HF.', 'detailedDescription': 'The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is a single-center observational study conducted in the 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Silesian Centre for Heart Disease in Zabrze, Poland.\n\nThe main objective of the DayCare-HF is to verify the hypothesis that comprehensive and multidisciplinary day-care management of patients with refractory heart failure (HF) is safe and beneficial in terms of hospital readmission due to HF and al cause mortality.\n\nThe study population is formed by selected patients with heart failure, hospitalized in cardiology wards and intensive cardiac care unit of Silesian Centre for Heart Disease, who fulfilled eligibility criteria.\n\nDuring the scheduled visits comprehensive medical service is provided, including education, diagnostic tools (electrocardiography, transthoracic echocardiography, implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy device (CRT) interrogation and additional treatment (intravenous loop diuretic, dobutamine, vasodilators administration).\n\nThe patients are under constant follow-up for major adverse events, heart transplantation, hospital readmissions due to HF and all cause mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Optimally decongested heart failure in New York Heart Association (NYHA) class II-IV, treated for at least 6 months\n2. Performance of all possible reparative procedures if indications were present (cardiac revascularization, correction of valvular heart disease, cardiac ablation, cardiac resynchronization therapy)\n3. Implantation of cardioverter-defibrillator (ICD) if applicable\n4. At least two unplanned hospitalizations for heart failure during preceding 6 months\n\nExclusion Criteria:\n\n1. Inability to travel to the unit\n2. Non-compliance with the medical recommendations'}, 'identificationModule': {'nctId': 'NCT03056651', 'acronym': 'DayCare-HF', 'briefTitle': 'Day-care Unit for Patients With Refractory Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Silesian Centre for Heart Diseases'}, 'officialTitle': 'Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study', 'orgStudyIdInfo': {'id': 'DayCare-HF'}, 'secondaryIdInfos': [{'id': 'DCHFU', 'type': 'OTHER', 'domain': 'Silesian Centre for Heart Disease'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DayCare-HF', 'description': 'Comprehensive service in day-care unit, including education, diagnostic tools (i.e. electrocardiography, transthoracic echocardiography, implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy device (CRT) interrogation and possibility of intravenous drug administration (i.e. loop diuretics, dobutamine).', 'interventionNames': ['Other: treatment in day-care heart failure unit']}], 'interventions': [{'name': 'treatment in day-care heart failure unit', 'type': 'OTHER', 'armGroupLabels': ['DayCare-HF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Silesian Centre for Heart Disease', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silesian Centre for Heart Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Professor', 'investigatorFullName': 'Mariusz Gasior', 'investigatorAffiliation': 'Silesian Centre for Heart Diseases'}}}}