Prevalence of Primary Aldosteronism in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ERETRIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973604
• Other study ID #: 4418/26/01/2021
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: Aristotle University Of Thessaloniki
• Contact: Maria Toumpourleka, MSc
• Phone: 00302310892343
• Email: m.toumpourleka[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hyperaldosteronism
• Primary Aldosteronism

Intervention

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).

Locations

Country	Name	City	State
Greece	Ippokratio General Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of primary aldosteronism in patients with atrial fibrillation	Percentage of patients with positive screening and confirmatory test for primary aldosteronism	Baseline
Secondary	Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation	Pulse wave velocity	Baseline
Secondary	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