Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT04000061
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2019-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Failure-USB: Prediction and Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2019-06-25', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of all-cause death', 'timeFrame': '1 to 8 years after hospitalization', 'description': 'number of all-cause death in patients hospitalized with ACS and AHF during the years 2010-2023.'}, {'measure': 'number of HF hospitalizations', 'timeFrame': '1 to 8 years after hospitalization', 'description': 'number of new HF hospitalizations in patients hospitalized with ACS and AHF during the years 2010-2023'}, {'measure': 'number of cardiovascular death', 'timeFrame': '1 to 8 years after hospitalization', 'description': 'number of cardiovascular death in patients hospitalized with ACS and AHF'}, {'measure': 'number of cardiovascular hospitalizations', 'timeFrame': '1 to 8 years after hospitalization', 'description': 'number of cardiovascular hospitalizations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Heart Failure', 'Acute Coronary Syndrome', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'This retrospective cohort study is to identify triggers of heart failure (HF) development and drivers of HF progression as well as the underlying cardiac disease (phenotype) to identify patients at risk and predict the clinical course of the disease. Data of patients who were hospitalized during the years 2010-2023 with acute coronary syndrome (ACS) and/ or with acute heart failure (AHF) will be collected and analyzed. In a subgroup cohort efficacy and safety of digoxin in patients with acute heart failure triggered by tachyarrhythmia will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that were hospitalized at the Universitätsspital Basel/ Switzerland with the diagnosis of ACS or AHF during the years 2010 - 2023', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized with a primary diagnosis of ACS\n* Patients hospitalized with a primary or secondary diagnosis of AHF\n\nExclusion Criteria:\n\n* Existence of a documented statement of the patient against the scientific use of clinical data'}, 'identificationModule': {'nctId': 'NCT04000061', 'briefTitle': 'Heart Failure-USB: Prediction and Progression', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Heart Failure-USB: Prediction and Progression', 'orgStudyIdInfo': {'id': '2019-00956; me19Mueller'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute coronary syndrome (ACS)', 'description': 'Outcome information (all-cause death, heart failure (HF) hospitalizations) of patients hospitalized with a primary diagnosis of ACS is analyzed.', 'interventionNames': ['Other: medical chart review', 'Other: data generated by direct IT export']}, {'label': 'acute heart failure (AHF)', 'description': 'Outcome information (all-cause death, heart failure (HF) hospitalizations) of patients hospitalized with a primary or secondary diagnosis of AHF is analyzed.', 'interventionNames': ['Other: medical chart review', 'Other: data generated by direct IT export']}], 'interventions': [{'name': 'medical chart review', 'type': 'OTHER', 'description': 'data generated by medical review include Medical history, Medications at presentation, during hospitalization and at discharge, New York Heart Association (NYHA) class, Killip class, Electrocardiographic (ECG) data, echocardiographic data, Interventions (Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG), Implantable Cardioverter Defibrillator (ICD) implantation, Cardiac Resynchronization Therapy (CRT) Implantation), Outcome Information: all-cause death, HF hospitalizations', 'armGroupLabels': ['acute coronary syndrome (ACS)', 'acute heart failure (AHF)']}, {'name': 'data generated by direct IT export', 'type': 'OTHER', 'description': 'data generated by direct IT export include Anthropometric data (age, sex, height, weight), Vital signs, Laboratory data', 'armGroupLabels': ['acute coronary syndrome (ACS)', 'acute heart failure (AHF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Christian Mueller, Prof. Dr.', 'role': 'CONTACT', 'email': 'Christian.mueller@usb.ch', 'phone': '+41 61 32 86 549'}], 'facility': 'Cardiology, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Christian Müller, Prof. Dr.', 'role': 'CONTACT', 'email': 'Christian.mueller@usb.ch', 'phone': '0041 6132 86 549'}, {'name': 'Fiona Nafaa, MD', 'role': 'CONTACT', 'email': 'fiona.nafaa@usb.ch', 'phone': '+41 61 32 87747'}], 'overallOfficials': [{'name': 'Christian Müller, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}