Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
Study NCT ID:
NCT06582992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-03
First Post:
2024-08-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DNA Methylation Trajectories in Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Isolation of circulating T lymphocytes and DNA extraction; isolation of plasma and protein detection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-31', 'studyFirstSubmitDate': '2024-08-31', 'studyFirstSubmitQcDate': '2024-08-31', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of differentially methylated positions and regions as assessed by RRBS', 'timeFrame': '6 months', 'description': 'We will identify a panel of positions and regions of the genome which are differentially methylated using as measure diff.meth more than or minor than 2 and p minor than 0.05'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Aging']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to profile changes in DNA methylation of circulating CD4+ T and CD8+ T cells from healthy young to aged with diagnosis of HFpEF, a particular phenotype of HF which is highly prevalent in aging.\n\nThe main question it aims to answer is:\n\n-Do DNA methylation biomarkers help us to understand the role of inflammation in HFpEF during aging?\n\nOur goal is to provide a simple large-scale panel of epigenetic-sensitive biomarkers useful in aged patients with HF in the early natural history of the disease (HFpEF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 150 subjects will be enrolled; n=50 healthy young, n=50 aged (≥65) without signs and symptoms of heart failure, and n=50 aged (≥65) with diagnosis of HFpEF will be enrolled at Trasfusion Medicine and Cardiology Departments of University of Campania Luigi Vanvitelli; Each group will be matched for sex (25 M and 25 F), smoker habits, and comorbidities. Demographic and clinical characteristics will be collected both from patients and healthy subjects at baseline. For HFpEF patients, echocardiographic parameters will be reported based on the echocardiogram acquired at the time of enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects aged between 18 and 40 years\n* Aged subjects (≥65) without signs and symptoms of heart failure\n* Aged subjects (≥65) with diagnosis of heart failure with preserved ejection fraction (EF major than 50%)\n\nExclusion Criteria:\n\n* Heart failure with reduced ejection fraction (EF minor than 40%)\n* Heart failure with mildly reduced EF (HFmrEF) (EF 41-49%)\n* History or diagnosis of cancer and inflammatory diseases'}, 'identificationModule': {'nctId': 'NCT06582992', 'acronym': 'EPI-GERAS', 'briefTitle': 'DNA Methylation Trajectories in Aging', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'EPIGENETIC-SENSITIVE BIOMARKERS OF INFLAMMAGING FROM HEALTHY TO HEART FAILURE DISEASE', 'orgStudyIdInfo': {'id': 'Aging Well in an Aging Society'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young healthy subjects', 'description': 'This cohort is characterized by 50 healthy subjects aged \\< 40 years (blood donor volonteers)', 'interventionNames': ['Other: RRBS']}, {'label': 'Aged healthy subjects', 'description': 'This cohort is characterized by 50 healthy subjects aged \\> 60-65 years (blood donor volonteers) without signs and symptoms of heart failure', 'interventionNames': ['Other: RRBS']}, {'label': 'Patients with heart failure', 'description': 'This cohort is characterized by 50 subjects aged \\> 60-65 years with signs and symptoms of heart failure with preserved ejection fraction', 'interventionNames': ['Other: RRBS']}], 'interventions': [{'name': 'RRBS', 'type': 'OTHER', 'otherNames': ['O-Link Targeted Proteomics'], 'description': 'Measure of genomic regions with differentially methylated profiles and differentially expressed protein', 'armGroupLabels': ['Aged healthy subjects', 'Patients with heart failure', 'Young healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80138', 'city': 'Naples', 'state': 'No States Available', 'country': 'Italy', 'contacts': [{'name': 'Giuditta Benincasa, PhD', 'role': 'CONTACT', 'phone': '3245511161'}, {'name': 'Giuditta Benincasa, PhD', 'role': 'CONTACT', 'email': 'giuditta.benincasa@unicampania.it', 'phone': '3245511161'}], 'facility': 'University of Campania Luigi Vanvitelli', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Giuditta Benincasa, PhD', 'role': 'CONTACT', 'email': 'giuditta.benincasa@unicampania.it', 'phone': '3245511161'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not required'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giuditta Benincasa', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}