Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-28 @ 4:49 PM
Study NCT ID:
NCT06515366
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MAP( Mean Arterial Pressure) and Mortality Relation in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'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': 'ESTIMATED', 'count': 280}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '1 month', 'description': 'patients having mortaility within 1 month of follow up'}], 'secondaryOutcomes': [{'measure': 're-hospitalization', 'timeFrame': '1 month', 'description': 'patients being re-hospitalized within 1 month after discharge from hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'mean arterial pressure', 'emergency department'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '37702595', 'type': 'BACKGROUND', 'citation': 'Ma H, Li H, Sheng S, Quan L, Yang Z, Xu F, Zeng W. Mean arterial pressure and mortality in patients with heart failure: a retrospective analysis of Zigong heart failure database. Blood Press Monit. 2023 Dec 1;28(6):343-350. doi: 10.1097/MBP.0000000000000674. Epub 2023 Sep 14.'}, {'pmid': '32819421', 'type': 'BACKGROUND', 'citation': 'Burstein B, Tabi M, Barsness GW, Bell MR, Kashani K, Jentzer JC. Association between mean arterial pressure during the first 24 hours and hospital mortality in patients with cardiogenic shock. Crit Care. 2020 Aug 20;24(1):513. doi: 10.1186/s13054-020-03217-6.'}, {'pmid': '37177860', 'type': 'BACKGROUND', 'citation': 'Gao Q, Lin Y, Xu R, Zhang Y, Luo F, Chen R, Li P, Nie S, Li Y, Su L. Association between mean arterial pressure and clinical outcomes among patients with heart failure. ESC Heart Fail. 2023 Aug;10(4):2362-2374. doi: 10.1002/ehf2.14401. Epub 2023 May 12.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this observational study is to evaluate the relationship between mean arterial pressure (MAP) and mortality in patients presenting to the emergency department with acute heart failure, focusing on emergency department monitoring and subgroup presentations. Our goal is to determine the impact of subgroup characteristics on mortality among patients presenting with heart failure in the emergency department, and to assess the predictive value and significance of MAP in predicting mortality.', 'detailedDescription': 'After obtaining ethical approval, the study will commence within 2 weeks and continue for 1 year. Based on clinical statistics or general literature data, and considering sample size calculations, a total of 280 patients across 4 groups have been determined.\n\nInclusion Criteria:\n\nAge 18 and above Patients presenting with symptoms of heart failure\n\nExclusion Criteria:\n\nAge under 18 Patients presenting with ST-elevation myocardial infarction Patients with acute kidney failure Pregnant patients Patients with inaccessible data for the parameters under study\n\nGroups based on initial mean arterial pressure (MAP) upon hospital admission will be established as follows: \\<65 mmHg, 66-80 mmHg, 81-100 mmHg, \\>100 mmHg. Data including results of emergency department tests and pertinent findings will be recorded for patients in these groups. The 30-day mortality rates of these patients will be statistically evaluated based on their MAP values and the procedures performed during emergency department monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients over the age of 18 with known heart failure, presenting to emergency department with acute exacerbation of heart failure symptoms will be grouped according to their measured mean arterial pressure (MAP)', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18 and above Patients presenting with symptoms of heart failure\n\nExclusion Criteria:\n\nAge under 18 Patients presenting with ST-elevation myocardial infarction Patients with acute kidney failure Pregnant patients Patients with inaccessible data for the parameters under study'}, 'identificationModule': {'nctId': 'NCT06515366', 'briefTitle': 'MAP( Mean Arterial Pressure) and Mortality Relation in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Evaluation of the Relationship Between Mean Arterial Pressure (MAP) and Mortality in Patients With Heart Failure: A Perspective From Emergency Department Monitoring and Hospital Presentation', 'orgStudyIdInfo': {'id': 'MAP and Mortality'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MAP ≤ 65 mmHg', 'description': 'patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure ≤ 65 mmHg'}, {'label': 'MAP 66-80 mmHg', 'description': 'patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between 66-80 mmHg'}, {'label': 'MAP 81-100 mmHg', 'description': 'patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between 81-100 mmHg'}, {'label': 'MAP >100 mmHg', 'description': 'patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between \\>100 mmHg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'state': 'Yenimahalle', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'gulsen akcay, ass. prof.', 'role': 'CONTACT', 'email': 'gulakcay@yahoo.com.tr', 'phone': '+905052874949'}, {'name': 'elif hamzacebioglu kayisoglu, specalist', 'role': 'CONTACT', 'email': 'turkuaz-61@windowslive.com', 'phone': '+905453300679'}, {'name': 'elif hamzacebioglu kayisoglu, specialist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'faruk meric, resident', 'role': 'SUB_INVESTIGATOR'}, {'name': 'gulsen akcay, ass. prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'bedriye muge sonmez, ass.prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'murat özdemir, specialist', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'gulsen akcay, ass. prof.', 'role': 'CONTACT', 'email': 'gulakcay@yahoo.com.tr', 'phone': '+905052874949'}, {'name': 'elif hamzacebioglu kayisoglu, specialist', 'role': 'CONTACT', 'email': 'turkuaz-61@windowslive.com', 'phone': '+905453300679'}], 'overallOfficials': [{'name': 'gulsen akcay, ass. prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ass. prof. of organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}