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UnknownNCT05973604

Prevalence of Primary Aldosteronism in Atrial Fibrillation

Prevalence of Primary Aldosteronism in Patients With Atrial Fibrillation (ERETRIA Trial)

Status
Unknown
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Aristotle University Of Thessaloniki · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

This is an observational prospective cross-sectional study, investigating the prevalence of primary aldosteronism in patients with atrial fibrillation.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTScreening and Confirmatory diagnostic test for primary aldosteronismScreening 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).

Timeline

Start date
2021-09-01
Primary completion
2024-09-01
Completion
2024-09-01
First posted
2023-08-03
Last updated
2023-08-03

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT05973604. Inclusion in this directory is not an endorsement.