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Prevalence of Primary Aldosteronism in Atrial Fibrillation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05973604
Acronym
ERETRIA
Enrollment
120
Registered
2023-08-03
Start date
2021-09-01
Completion date
2024-09-30
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Primary Aldosteronism

Keywords

Atrial Fibrillation, Primary Aldosteronism

Brief summary

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

Interventions

DIAGNOSTIC_TESTScreening 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).

Sponsors

Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Established diagnosis of atrial fibrillation with a standard surface ECG tracing of at least 30 seconds (either paroxysmal or persistent or permanent).

Exclusion criteria

* Diagnosis of primary aldosteronism * 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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of primary aldosteronism in patients with atrial fibrillationBaselinePercentage of patients with positive screening and confirmatory test for primary aldosteronism

Secondary

MeasureTime frameDescription
Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillationBaselinePulse wave velocity
Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation.BaselineLeft ventricular global longitudinal strain (GLS) measured by transthoracic echocardiography

Countries

Greece

Contacts

Primary ContactMaria Toumpourleka, MSc
m.toumpourleka@gmail.com00302310892343
Backup ContactVassilios P Vassilikos, PhD
vvassil@auth.gr00302310892343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026