Clincosm LogoSign in Get a demo

ERETRIA: Prevalence of Primary Aldosteronism in Atrial Fibrillation

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Recruiting
CT.gov ID
NCT05973604
Collaborator
(none)
120
Enrollment
1
Location
36
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Screening and Confirmatory diagnostic test for primary aldosteronism

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prevalence of Primary Aldosteronism in Patients With Atrial Fibrillation (ERETRIA Trial)
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Prevalence of primary aldosteronism in patients with atrial fibrillation [Baseline]

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

Secondary Outcome Measures

  1. Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation [Baseline]

    Pulse wave velocity

  2. Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation. [Baseline]

    Left ventricular global longitudinal strain (GLS) measured by transthoracic echocardiography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ippokratio General Hospital Thessaloniki Greece 54642

Sponsors and Collaborators

  • Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Maria Toumpourleka, MSc, Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
  • Study Director: 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 Chair: Christodoulos E Papadoupoulos, Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Toumpourleka, Principal Investigator, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT05973604
Other Study ID Numbers:
  • 4418/26/01/2021
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria Toumpourleka, Principal Investigator, Aristotle University Of Thessaloniki
Atrial Fibrillation
Primary Aldosteronism
Additional relevant MeSH terms:
Atrial Fibrillation
Hyperaldosteronism

Study Results

No Results Posted as of Aug 3, 2023