Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT05710302
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2023-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Validation of the Emergency Heart Failure Mortality Risk Grade (EHMRG) Score in Patients With Acute Heart Failure in the Emergency Department
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': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '7 days', 'description': 'Death within 7 days after emergency department presentation for acute heart failure.'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Death within 30 days after emergency department presentation for acute heart failure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mortality', 'emergency department', 'heart failure', 'hospitalization', 'risk assessment', 'discharge planning'], 'conditions': ['Heart Failure', 'Heart Diseases', 'Acute Heart Failure']}, 'referencesModule': {'references': [{'pmid': '27823694', 'type': 'RESULT', 'citation': 'Lee DS, Lee JS, Schull MJ, Grimshaw JM, Austin PC, Tu JV. Design and rationale for the Acute Congestive Heart Failure Urgent Care Evaluation: The ACUTE Study. Am Heart J. 2016 Nov;181:60-65. doi: 10.1016/j.ahj.2016.07.016. Epub 2016 Aug 7.'}, {'pmid': '35277803', 'type': 'RESULT', 'citation': 'van Hattem NE, Beeres SLMA, Mertens BJA, Antoni ML, Atsma DE, Schalij MJ, den Haan MC. Emergency Heart failure Mortality Risk Grade may help to reduce heart failure admissions. Neth Heart J. 2022 Sep;30(9):431-435. doi: 10.1007/s12471-022-01661-3. Epub 2022 Mar 11.'}, {'pmid': '30586748', 'type': 'RESULT', 'citation': "Lee DS, Lee JS, Schull MJ, Borgundvaag B, Edmonds ML, Ivankovic M, McLeod SL, Dreyer JF, Sabbah S, Levy PD, O'Neill T, Chong A, Stukel TA, Austin PC, Tu JV. Prospective Validation of the Emergency Heart Failure Mortality Risk Grade for Acute Heart Failure. Circulation. 2019 Feb 26;139(9):1146-1156. doi: 10.1161/CIRCULATIONAHA.118.035509."}, {'pmid': '22665814', 'type': 'RESULT', 'citation': 'Lee DS, Stitt A, Austin PC, Stukel TA, Schull MJ, Chong A, Newton GE, Lee JS, Tu JV. Prediction of heart failure mortality in emergent care: a cohort study. Ann Intern Med. 2012 Jun 5;156(11):767-75, W-261, W-262. doi: 10.7326/0003-4819-156-11-201206050-00003.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/27823694/', 'label': 'Design and rationale for the Acute Congestive Heart Failure Urgent Care Evaluation: The ACUTE Study.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/35277803/', 'label': 'Emergency Heart failure Mortality Risk Grade may help to reduce heart failure admissions.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30586748/', 'label': 'Prospective Validation of the Emergency Heart Failure Mortality Risk Grade for Acute Heart Failure.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/22665814/', 'label': 'Prediction of heart failure mortality in emergent care: a cohort study.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective validation study, researchers investigates accuracy of EHMRG (Emergency Heart Failure Mortality Risk Grade) score in predicting the 7th and 30th day risk of mortality in patients with acute heart failure who applying to the emergency department.', 'detailedDescription': "Heart failure is a serious public health problem in the world due to its high morbidity and mortality rate.Turkish Society of Cardiology conducted a prevalence study. The name of the study is HAPPY. Accordingly, the prevalence of heart failure in people over 35 years of age in Turkey is 2.9%.The prevalence of heart failure in Turkey is higher than in European countries.\n\nThe incidence of heart failure cases with no obvious symptoms is 4.9% in Turkey. Patients with a diagnosis of heart failure apply to the emergency department frequently. There are scoring studies around the world for patients' hospitalization and discharge.\n\nEHMRG score created and validated by Douglas S. Lee et al. In our study, the accuracy of EHMRG score will be investigated prospectively in patients diagnosed with acute heart failure in the emergency department."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with acute heart failure in the emergency department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with acute heart failure in the emergency department\n\nExclusion Criteria:\n\n* Dialysis dependent patients\n* Pregnant patients\n* Patients brought to the emergency department with cardiac arrest'}, 'identificationModule': {'nctId': 'NCT05710302', 'briefTitle': 'Prospective Validation of the Emergency Heart Failure Mortality Risk Grade (EHMRG) Score in Patients With Acute Heart Failure in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University Pendik Training and Research Hospital'}, 'officialTitle': 'Investigation of the Diagnostic Accuracy of EHMRG Risk Score in Patients With Acute Heart Failure', 'orgStudyIdInfo': {'id': '09.2022.742'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients diagnosed with acute heart failure in the emergency department', 'description': 'Patients with acute heart failure.', 'interventionNames': ['Other: Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute heart failure']}], 'interventions': [{'name': 'Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute heart failure', 'type': 'OTHER', 'description': 'Prospective validation of the EHMRG score in patients with acute heart failure in the emergency department', 'armGroupLabels': ['Patients diagnosed with acute heart failure in the emergency department']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Pendik Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Berkay UNLU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University School of Medicine Emergency Department'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '6 months', 'ipdSharing': 'YES', 'description': 'The study plan, collected data and statistical analyzes will be shared with the researchers.', 'accessCriteria': 'Ethics Committee Approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University Pendik Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Berkay Ünlü', 'investigatorAffiliation': 'Marmara University Pendik Training and Research Hospital'}}}}