Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-08 @ 4:27 AM
Study NCT ID:
NCT03784833
Status:
UNKNOWN
Last Update Posted:
2019-04-23
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry Study of Biomarkers in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'Blood Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-21', 'studyFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2018-12-20', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of death (all cause)', 'timeFrame': '2 years of follow-up', 'description': 'Number of death within 2 years of discharge'}], 'secondaryOutcomes': [{'measure': 'Number of rehospitalizations for acute heart failure (HF)', 'timeFrame': '2 years of follow-up', 'description': 'Number of heart failure related hospitalization within 2 years of discharge'}, {'measure': 'Number of death ( all cause) or readmission for heart failure', 'timeFrame': '2 years of follow-up', 'description': 'Number of Death or heart failure related hospitalization within 2 years of discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The registry study aims to discover the prognostic value of bio-markers in heart failure', 'detailedDescription': "The purpose of this study is to investigate the prognostic value of biomarkers in Heart Failure.Patients with confirmed diagnosis of heart failure are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with heart failure accorrding to Inclusion and exclusion criteria.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years at the time of admission to the hospital\n* With symptoms of new-onset or worsening heart failure\n* Received or is eligible to receive a principal hospital discharge diagnosis of HF\n* With signs and syndromes as follows: dyspnea at rest or with minimal exertion (dyspnea, orthopnea, or edema)；Rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.\n* Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken;\n\nExclusion Criteria:\n\n* Have objective evidence of cardiac dysfunction documented either by plasma concentrations of BNP and/or N-terminal pro-brain natriuretic peptide (NT-proBNP) \\<35 pg/mL or \\<125 pg/ml, respectively\n* Current known inability to follow instructions or comply with follow-up procedures.\n* Eligible patients without informed consent form'}, 'identificationModule': {'nctId': 'NCT03784833', 'acronym': 'BIOMS-HF', 'briefTitle': 'A Registry Study of Biomarkers in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases'}, 'officialTitle': 'A Registry Study of Biomarkers in Heart Failure', 'orgStudyIdInfo': {'id': 'BIOMS-HF'}}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan WANG, PhD', 'role': 'CONTACT', 'email': 'wangyuan980510@163.com', 'phone': '86-010-64456169'}, {'name': 'Jie DU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yuan Wang, Dr', 'role': 'CONTACT', 'email': 'wangyuan980510@163.com', 'phone': '13910161443'}, {'name': 'Bingbing Ke, Dr', 'role': 'CONTACT', 'email': '1017120710@qq.com', 'phone': '15510286857'}], 'overallOfficials': [{'name': 'Jie Du, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin Medical University Second Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Beijing Luhe Hospital', 'class': 'OTHER'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}