Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-13 @ 10:30 PM
Study NCT ID:
NCT06491628
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Function Abnormalities in Patients With Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-27', 'releaseDate': '2025-08-10'}], 'estimatedResultsFirstSubmitDate': '2025-08-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals', 'timeFrame': 'baseline', 'description': 'assessment the LFTs abnormalities and factors mediating hepatic impairment in patients with AHF'}], 'secondaryOutcomes': [{'measure': 'Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals', 'timeFrame': '1 year', 'description': 'assessment the LFTs abnormalities and factors mediating hepatic impairment in patients with AHF'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LFTs, AHF'], 'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate liver function test abnormalities and to identify associated cardiac and non cardiac factors mediating hepatic impairment in acute heart failure patients', 'detailedDescription': 'Cardiac failure has a negative impact on the function of all parenchymatous organs, based both on the low organ perfusion in the left-sided failure and on the venous congestion in the right-sided failure.\n\nThe pathophysiology of acute heart failure (AHF) is complex and not fully understood. It has been hypothesized that an episode of acute decompensation affects not only the cardiovascular system itself, but may also deteriorate the function of other organs, c ausing serious clinical consequences. Liver involvement has been mostly described and investigated in patients with chronic HF.\n\nLiver enzyme alterations are usually classified as relating predominantly to liver cell necrosis (signified by transaminase elevations) or predominantly to cholestasis (signified by elevated alkaline phosphatase (AP) level).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged 18 yrs or older presenting with AHF', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18 yrs or older presenting with AHF\n\nExclusion Criteria:\n\n* Congenital heart disease\n* acute and chronic liver diseases'}, 'identificationModule': {'nctId': 'NCT06491628', 'briefTitle': 'Liver Function Abnormalities in Patients With Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Liver Function Abnormalities in Patients With Acute Heart Failure in Sohag University Hospitals', 'orgStudyIdInfo': {'id': 'LFTs abnormalities in AHF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute decompensated heart failure (de novo or as decompensation of chronic heart failure)', 'description': 'This umbrella term includes patients presenting forthe first time with typical symptoms and signs of heart failure(de novo AHF) and also those with worsening of their pre-existing cardiomyopathy (acute decompensated heart failure).', 'interventionNames': ['Behavioral: Avoiding the risk factors']}, {'label': 'Pulmonary edema', 'description': "It's the real clinical presentation of AHF, typically, signs and symptoms develope rapidly and patients demonstrate severe respiratory distress with tachypnea, orthopnea and pulmonary congestion", 'interventionNames': ['Behavioral: Avoiding the risk factors']}, {'label': 'Hypertensive acute heart failure', 'description': 'the condition is associated with elevated blood pressure with accompanying dyspnea. orthopnea and pulmonary congestion, often in patients with relatively preserved left ventricle ejection fraction', 'interventionNames': ['Behavioral: Avoiding the risk factors']}, {'label': 'cardiogenic shock', 'description': "severe peripheral hypoperfusion wih subsequent end organs damage,typically it's associated with low blood pressure and low urine output", 'interventionNames': ['Behavioral: Avoiding the risk factors']}, {'label': 'Acute coronary syndrome complicated by heart failure', 'description': 'characterized by complex structural, hemodynamic and neurohormonal interaction need urgent referral for coronary intervention poor outcome', 'interventionNames': ['Behavioral: Avoiding the risk factors']}], 'interventions': [{'name': 'Avoiding the risk factors', 'type': 'BEHAVIORAL', 'description': 'Exercise, Salt and lipid reduction in diet, smoking cessation', 'armGroupLabels': ['Acute coronary syndrome complicated by heart failure', 'Acute decompensated heart failure (de novo or as decompensation of chronic heart failure)', 'Hypertensive acute heart failure', 'Pulmonary edema', 'cardiogenic shock']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Sara Mohamed', 'role': 'CONTACT', 'email': 'Sara_mohamed_post@med.Sohag.edu.eg', 'phone': '+201117517685'}, {'name': 'Hassan Ahmed', 'role': 'CONTACT', 'phone': '+201003459741'}], 'overallOfficials': [{'name': 'Hamdy Saad', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}, {'name': 'Haitham Mohammad', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals', 'investigatorFullName': 'Sara Mohamed Saber', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-10', 'type': 'RELEASE'}, {'date': '2025-08-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sara Mohamed Saber, Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals, Sohag University'}}}}