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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05973604
Other study ID # 4418/26/01/2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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