Prevalence of Primary Aldosteronism in Atrial Fibrillation

NCT ID: NCT05973604

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-09-30

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.

Detailed Description

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Conditions

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Atrial Fibrillation Primary Aldosteronism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Maria Toumpourleka

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Toumpourleka, MSc

Role: PRINCIPAL_INVESTIGATOR

Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece

Vassilios P Vassilikos, PhD

Role: STUDY_DIRECTOR

Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece

Michael Doumas, PhD

Role: STUDY_DIRECTOR

Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece

Christodoulos E Papadoupoulos

Role: STUDY_CHAIR

Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece

Locations

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Ippokratio General Hospital

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Maria Toumpourleka, MSc

Role: CONTACT

00302310892343

Vassilios P Vassilikos, PhD

Role: CONTACT

00302310892343

Facility Contacts

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Maria Toumpourleka, MSc

Role: primary

00302310892343

Other Identifiers

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4418/26/01/2021

Identifier Type: -

Identifier Source: org_study_id

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