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Prevalence of Primary Aldosteronism in Atrial Fibrillation

NCT05973604 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-08-03

No results posted yet for this study

Summary

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Maria Toumpourleka, MSc · Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece

  • Vassilios P Vassilikos, PhD · Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece

  • Michael Doumas, PhD · Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece

  • Christodoulos E Papadoupoulos · Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-09-01
Completion
2024-09-30

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973604 on ClinicalTrials.gov