Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 10:40 AM
Study NCT ID:
NCT04941794
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'HOMA-IR', 'timeFrame': 'During 5 year follow-up', 'description': 'Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)'}], 'primaryOutcomes': [{'measure': 'Chronic Heart Failure', 'timeFrame': 'During 5 year follow up', 'description': 'Determined by echocardiography according to European Society of Cardiology (ESC) definitions'}], 'secondaryOutcomes': [{'measure': 'NT-ProBNP', 'timeFrame': 'During 5 year follow up', 'description': 'Change in N-terminal prohormone of brain natriuretic peptide (NT-ProBNP)'}, {'measure': 'hs-CRP', 'timeFrame': 'During 5 year follow up', 'description': 'Change in High-sensitivity C-reactive protein (hs-CRP)'}, {'measure': 'Troponin', 'timeFrame': 'During 5 year follow up', 'description': 'Change in Troponin'}, {'measure': '6 minutes walk test', 'timeFrame': 'During 5 year follow up', 'description': 'Change in 6 minutes walk test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure.', 'detailedDescription': 'A cohort study on 500 patients with type 2 diabetes without known heart disease and age \\> 50 years of age. On inclusion and on yearly basis, patients are evaluated by echocardiography, ECG, blood tests to examine NT-ProBNP, hs-CRP, troponin, kidney function and 6 minutes hall walk test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '500 patients with known type 2 diabetes who are treated at the department of endocrinology, North Denmark Regional Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* age \\> 50 years\n\nExclusion Criteria:\n\n* History of acute or chronic heart failure\n* History of ischemic heart disease'}, 'identificationModule': {'nctId': 'NCT04941794', 'briefTitle': 'Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Regionshospital Nordjylland'}, 'officialTitle': 'Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'N-20210021'}}, 'contactsLocationsModule': {'locations': [{'zip': '9800', 'city': 'Hjørring', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Steen Hyldgaard, MD', 'role': 'CONTACT', 'email': 's.joergensen@rn.dk'}], 'facility': 'North Denmark Regional Hospital', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}], 'centralContacts': [{'name': 'Peter Leutscher, Professor', 'role': 'CONTACT', 'email': 'p.leutscher@rn.dk', 'phone': '0045 9764 2652'}, {'name': 'Isabelle Larsen, RN', 'role': 'CONTACT', 'email': 'isml@rn.dk', 'phone': '0045 2041 6541'}], 'overallOfficials': [{'name': 'Steen Hylgaard Jørgensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionshospital Nordjylland', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}