Prevalence of Primary Aldosteronism in Atrial Fibrillation

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

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

Conditions
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Atrial Fibrillation, Primary Aldosteronism

Intervention / Treatment
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* Diagnostic Test: Screening and Confirmatory diagnostic test for primary aldosteronism


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of primary aldosteronism in patients with atrial fibrillation | Percentage of patients with positive screening and confirmatory test for primary aldosteronism | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation | Pulse wave velocity | Baseline | 
| Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation. | Left ventricular global longitudinal strain (GLS) measured by transthoracic echocardiography | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Primary Aldosteronism