Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-17 @ 2:33 PM
Study NCT ID:
NCT02487056
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2015-06-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Journey in Hospital With Heart Failure in Turkish Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003710', 'term': 'Demography'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mehdi_zoghi@hotmail.com', 'phone': '3904001', 'title': 'Dr. Mehdi Zoghi', 'organization': 'Cardiovascular Academy Society'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Although participant sites were encouraged to enroll patients, as consecutively as possible, the study population may not represent the general population. Registry data are based only on documentation of medical history and management during hospitalization, and follow-up data are not obtained. The medication dosage was not recorded, so we are not sure if the patients are taking the appropriate doses of HF medications.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Hospitalized Patients With Acute Heart Failure', 'description': 'The Journey HF-TR study is a cross-sectional, multicenter, non-invasive and observational trial that was conducted in intensive/coronary care units and cardiology wards. The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units between September 2015 and 2016 were included in our study.', 'otherNumAtRisk': 1606, 'deathsNumAtRisk': 1606, 'otherNumAffected': 0, 'seriousNumAtRisk': 1606, 'deathsNumAffected': 122, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence to European Heart Failure Guideline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1606', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hospitalized Patients With Acute Heart Failure', 'description': 'The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units'}], 'classes': [{'categories': [{'measurements': [{'value': '1172', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Admission to Hospital (Enrollment)', 'description': 'To assess number of patients managed and treated following the last European Heart Failure Guidelines', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospitalisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1606', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JourneyHF-TR', 'description': 'The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units between September 2015 and 2016 were included in our study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'In-Hospital', 'description': 'Length of stay in hospital in Turkish population admitted to study', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1606', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JourneyHF-TR', 'description': 'The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units between September 2015 and 2016 were included in our study.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'All cause death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'JourneyHF-TR', 'description': 'The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units between September 2015 and 2016 were included in our study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1622'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1606'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1606', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'JourneyHF-TR', 'description': 'The patients who were hospitalized with the diagnosis of acute heart failure in intensive/coronary care units between September 2015 and 2016 were included in our study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '688', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '918', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1622}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2015-06-23', 'resultsFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-26', 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to European Heart Failure Guideline', 'timeFrame': 'Admission to Hospital (Enrollment)', 'description': 'To assess number of patients managed and treated following the last European Heart Failure Guidelines'}], 'secondaryOutcomes': [{'measure': 'Length of Hospitalisation', 'timeFrame': 'In-Hospital', 'description': 'Length of stay in hospital in Turkish population admitted to study'}, {'measure': 'Mortality', 'timeFrame': '1 month', 'description': 'All cause death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Diagnosis', 'Management'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '30587703', 'type': 'RESULT', 'citation': 'Sinan UY, Ekmekci A, Ozbay B, Akyildiz Akcay F, Bekar L, Koza Y, Bolat I, Kocabas U, Zoghi M; Collaborators. The real-life data of hospitalized patients with heart failure: On behalf of the Journey HF-TR study investigators. Anatol J Cardiol. 2019 Jan;21(1):25-30. doi: 10.14744/AnatolJCardiol.2018.50880.'}, {'pmid': '36680444', 'type': 'RESULT', 'citation': 'Sabanoglu C, Sinan UY, Akboga MK, Coner A, Gok G, Kocabas U, Bekar L, Gazi E, Cengiz M, Kilic S, Inanc IH, Cakmak HA, Zoghi M. Long-Term Prognosis of Patients with Heart Failure: Follow-Up Results of Journey HF-TR Study Population. Anatol J Cardiol. 2023 Jan;27(1):26-33. doi: 10.14744/AnatolJCardiol.2022.2171.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compose a national database of the etiologies, clinical and demographic characteristics, using diagnostic tests, precipitating and risk factors, management of from intensive care unit or coronary care unit to hospital discharge, length of stay in the intensive care unit and hospital, in-hospital mortality and discharge medications of hospitalized acute heart failure patients in Turkish population.', 'detailedDescription': 'The etiologies, precipitating factors, demographics, clinical characteristics, management and outcome of patients admitted in hospital with acute heart failure in Turkish population will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients with acute heart failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years olds\n* Clinical diagnosis of acute heart failure\n* Admitted to the participating hospitals\n\nExclusion Criteria:\n\n* Patients \\<18 years old\n* Patients with acute heart failure who are discharged from the emergency room without admission.\n* Failure to obtain informed consent'}, 'identificationModule': {'nctId': 'NCT02487056', 'acronym': 'JournayHF-TR', 'briefTitle': 'Patient Journey in Hospital With Heart Failure in Turkish Population', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'A Multicentre, Prospective, Observational, Hospital-based Registry of Patients With Acute Heart Failure Those Whose Care Was Guided by a Cardiologist in Turkey', 'orgStudyIdInfo': {'id': 'JournayHF-TR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospitalized AHF', 'description': 'Patients who were hospitalized with a diagnosis of AHF in the intensive care unit (ICU)/coronary care unit and cardiology wards', 'interventionNames': ['Behavioral: Demographic and clinical characteristics, clinical history, symptoms and signs, initial emergency department evaluation, and subsequent inpatient management of HF patients']}], 'interventions': [{'name': 'Demographic and clinical characteristics, clinical history, symptoms and signs, initial emergency department evaluation, and subsequent inpatient management of HF patients', 'type': 'BEHAVIORAL', 'description': 'Demographic and clinical characteristics, clinical history, symptoms and signs, initial emergency department evaluation, and subsequent inpatient management of patients were recorded.', 'armGroupLabels': ['Hospitalized AHF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Ahmet Ekmekçi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ahmet Ekmekçi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Prof. Dr. Mehdi Zoghi', 'investigatorAffiliation': 'Ege University'}}}}