Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-31 @ 10:15 PM
Study NCT ID:
NCT05973604
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Primary Aldosteronism in Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006929', 'term': 'Hyperaldosteronism'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of primary aldosteronism in patients with atrial fibrillation', 'timeFrame': 'Baseline', 'description': 'Percentage of patients with positive screening and confirmatory test for primary aldosteronism'}], 'secondaryOutcomes': [{'measure': 'Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation', 'timeFrame': 'Baseline', 'description': 'Pulse wave velocity'}, {'measure': 'Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation.', 'timeFrame': 'Baseline', 'description': 'Left ventricular global longitudinal strain (GLS) measured by transthoracic echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Primary Aldosteronism'], 'conditions': ['Atrial Fibrillation', 'Primary Aldosteronism']}, 'descriptionModule': {'briefSummary': 'This is an observational prospective cross-sectional study, investigating the prevalence of primary aldosteronism in patients with atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established diagnosis of atrial fibrillation with a standard surface ECG tracing of at least 30 seconds (either paroxysmal or persistent or permanent).\n\nExclusion Criteria:\n\n* Diagnosis of primary aldosteronism\n* Diagnosis of heart failure, treated with mineralocorticoid receptor antagonists\n* Inability to be subjected to any confirmatory tests for primary aldosteronism\n* Acute vascular event (acute coronary syndrome, stroke, acute peripheral vascular event) within last 6 months\n* Renal replacement therapy\n* Incompetence of unwillingness to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT05973604', 'acronym': 'ERETRIA', 'briefTitle': 'Prevalence of Primary Aldosteronism in Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Prevalence of Primary Aldosteronism in Patients With Atrial Fibrillation (ERETRIA Trial)', 'orgStudyIdInfo': {'id': '4418/26/01/2021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Screening and Confirmatory diagnostic test for primary aldosteronism', 'type': 'DIAGNOSTIC_TEST', 'description': 'Screening for primary aldosteronism will be performed with measurement of aldosterone-to-renin ratio after 2 hours of bed rest. Renin measurement will be performed by estimating plasma renin activity. The screening test will be considered positive when the ratio is \\>30, accompanied by elevated aldosterone values (\\>15 ng/ml). Patients with a positive result will undergo further confirmatory testing with intravenous sodium test (administration 2 liters of normal saline N/S 0.9%, over a period of 4 hours, while the patient is supine. Considered positive if aldosterone levels are \\>5mg/dl at the end of the test). Alternative confirmatory methods are captopril test (Administration of 50 mg of captopril. Considered positive when aldosterone levels are \\>8.5 mg/dl 2 hours after the intake) or hydrocortisone test (Administration of 0.1mg of hydrocortisone 4 times a day for a period of 4 days. Considered positive if elevated aldosterone levels (\\>6ng/dl) are found at the end of the test).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54642', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Maria Toumpourleka, MSc', 'role': 'CONTACT', 'email': 'm.toumpourleka@gmail.com', 'phone': '00302310892343'}, {'name': 'Maria Toumpourleka, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vassilios P Vassilikos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Doumas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christodoulos E Papadopoulos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ippokratio General Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Maria Toumpourleka, MSc', 'role': 'CONTACT', 'email': 'm.toumpourleka@gmail.com', 'phone': '00302310892343'}, {'name': 'Vassilios P Vassilikos, PhD', 'role': 'CONTACT', 'email': 'vvassil@auth.gr', 'phone': '00302310892343'}], 'overallOfficials': [{'name': 'Maria Toumpourleka, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece'}, {'name': 'Vassilios P Vassilikos, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece'}, {'name': 'Michael Doumas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece'}, {'name': 'Christodoulos E Papadoupoulos', 'role': 'STUDY_CHAIR', 'affiliation': 'Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Toumpourleka', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}