Prevalence of Primary Aldosteronism in Atrial Fibrillation

NCT05973604 | Unknown

• 1 other identifier: 4418/26/01/2021
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation; Primary Aldosteronism

Keywords

Atrial Fibrillation; Primary Aldosteronism

Outcome Measures

Primary Outcomes (1)

• Prevalence of primary aldosteronism in patients with atrial fibrillation

  Percentage of patients with positive screening and confirmatory test for primary aldosteronism

  Baseline

Secondary Outcomes (2)

• Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation

  Baseline

• Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation.

  Baseline

Interventions

Screening and Confirmatory diagnostic test for primary aldosteronism DIAGNOSTIC_TEST

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).

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation

You may qualify if:

• Established diagnosis of atrial fibrillation with a standard surface ECG tracing of at least 30 seconds (either paroxysmal or persistent or permanent).

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Ippokratio General Hospital

Thessaloniki, 54642, Greece

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Hyperaldosteronism

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Maria Toumpourleka, MSc

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

  PRINCIPAL INVESTIGATOR

• Vassilios P Vassilikos, PhD

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

  STUDY DIRECTOR

• Michael Doumas, PhD

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

  STUDY DIRECTOR

• Christodoulos E Papadoupoulos

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

  STUDY CHAIR

Central Study Contacts

Maria Toumpourleka, MSc

CONTACT

00302310892343; m.toumpourleka@gmail.com

Vassilios P Vassilikos, PhD

CONTACT

00302310892343; vvassil@auth.gr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 3, 2023
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

GR (1)