Prevalence of Primary Aldosteronism in Atrial Fibrillation
NCT ID: NCT05973604
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2021-09-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Screening and Confirmatory diagnostic test for primary aldosteronism
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diagnosis of heart failure, treated with mineralocorticoid receptor antagonists
* Inability to be subjected to any confirmatory tests for primary aldosteronism
* Acute vascular event (acute coronary syndrome, stroke, acute peripheral vascular event) within last 6 months
* Renal replacement therapy
* Incompetence of unwillingness to provide written informed consent
18 Years
100 Years
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Maria Toumpourleka
Principal Investigator
Principal Investigators
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Maria Toumpourleka, MSc
Role: PRINCIPAL_INVESTIGATOR
Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
Vassilios P Vassilikos, PhD
Role: STUDY_DIRECTOR
Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
Michael Doumas, PhD
Role: STUDY_DIRECTOR
Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
Christodoulos E Papadoupoulos
Role: STUDY_CHAIR
Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
Locations
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Ippokratio General Hospital
Thessaloniki, , Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4418/26/01/2021
Identifier Type: -
Identifier Source: org_study_id
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