Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05090202
Status:
UNKNOWN
Last Update Posted:
2023-01-03
First Post:
2021-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediabetes and Newly Diagnosed Diabetes in Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2023-01-20', 'unreleaseDate': '2023-01-30'}, {'resetDate': '2023-11-07', 'releaseDate': '2023-01-30'}], 'estimatedResultsFirstSubmitDate': '2023-01-20'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-30', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart failure hospitalization.', 'timeFrame': 'From date of randomization up to 1 month', 'description': 'Heart failure hospitalization or cardiovascular (CV) death, and all-cause death, and estimated hazard ratios (HR) by use of multivariable Cox regression models.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '27473218', 'type': 'BACKGROUND', 'citation': 'Nielsen R, Jorsal A, Iversen P, Tolbod L, Bouchelouche K, Sorensen J, Harms HJ, Flyvbjerg A, Botker HE, Wiggers H. Heart failure patients with prediabetes and newly diagnosed diabetes display abnormalities in myocardial metabolism. J Nucl Cardiol. 2018 Feb;25(1):169-176. doi: 10.1007/s12350-016-0622-0. Epub 2016 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The aim the study is to determine the prevalence of prediabetic dysglycemia and newly diagnosed diabetes among individuals with CHF(chronic heart failure) in sohag university hospital patients .', 'detailedDescription': '\\- Prospective study to:\n\n1. study the differences in the prevalence of Prediabetes and newly diagnosed diabetes among the patients with HFrEF and HFpEF\n2. The effect of dysglycemia on prognosis of patients with chronic heart failure.\n3. The effect of early discover of diabetes mellitus on prognosis of patients with chronic heart failure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presented by heart failure NYHA class 2 or more and admitted to Sohag University hospital according to inclusion and exclusion criterea', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* All patients presented by heart failure\n* 18 years or older\n* Classified according to NYHA " New York Heart Association" classification from NYHA class 2 and more\n\nExclusion Criteria:\n\n* Overt diabetes\n* Rheumatic Heart Disease\n* Congenital heart disease'}, 'identificationModule': {'nctId': 'NCT05090202', 'briefTitle': 'Prediabetes and Newly Diagnosed Diabetes in Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Prevalence of Prediabetes and Newly Diagnosed Diabetes in Patients With HFpEF( Heart Failure With Preserved Ejection Fraction) and HFrEF(Heart Failure With Reduced Ejection Fraction) in Sohag University Hospital', 'orgStudyIdInfo': {'id': 'diabetes and heart failure'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HFrEF " Heart failure with reduced ejection fraction"', 'description': 'chronic heart failure with echocardiographic finding of LVEF "Left ventricular ejection fraction" equal or less than 40%', 'interventionNames': ['Diagnostic Test: hbA1C']}, {'label': 'HFmrEF "Heart failure with mildly reduced ejection fraction"', 'description': 'chronic heart failure with echocardiographic finding of LVEF between 41% and 49%', 'interventionNames': ['Diagnostic Test: hbA1C']}, {'label': 'HFpEF " Heart failure with preserved ejection fraction"', 'description': 'chronic heart failure with echocardiographic finding of LVEF equal or more than 50%', 'interventionNames': ['Diagnostic Test: hbA1C']}], 'interventions': [{'name': 'hbA1C', 'type': 'DIAGNOSTIC_TEST', 'description': 'hbA1C will be measured for all patients and results will be analysed into Non diabetic, Prediabetic and Diabetic', 'armGroupLabels': ['HFmrEF "Heart failure with mildly reduced ejection fraction"', 'HFpEF " Heart failure with preserved ejection fraction"', 'HFrEF " Heart failure with reduced ejection fraction"']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Heba S AbdelKader', 'role': 'CONTACT', 'email': 'heba011214@med.sohag.edu.eg', 'phone': '01067892227'}, {'name': 'Hassan A Hasanien, prof', 'role': 'CONTACT', 'phone': '01003459741'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heba Saber AbdelKader', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-01-20', 'type': 'RELEASE'}, {'date': '2023-01-30', 'type': 'UNRELEASE'}, {'date': '2023-01-30', 'type': 'RELEASE'}, {'date': '2023-11-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Heba Saber AbdelKader, Principal Investigator, Sohag University'}}}}