Prevalence of Primary Aldosteronism in Atrial Fibrillation (ERETRIA)

August 1, 2023 updated by: Maria Toumpourleka, Aristotle University Of Thessaloniki

Prevalence of Primary Aldosteronism in Patients With Atrial Fibrillation (ERETRIA Trial)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Vassilios P Vassilikos, PhD
  • Phone Number: 00302310892343
  • Email: vvassil@auth.gr

Study Locations

  • Greece
      • Thessaloniki, Greece, 54642
        • Recruiting
        • Ippokratio General Hospital
        • Contact:
        • Principal Investigator:
          • Maria Toumpourleka, MSc
        • Principal Investigator:
          • Vassilios P Vassilikos, PhD
        • Principal Investigator:
          • Michael Doumas, PhD
        • Principal Investigator:
          • Christodoulos E Papadopoulos, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with atrial fibrillation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of primary aldosteronism in patients with atrial fibrillation
Time Frame: Baseline
Percentage of patients with positive screening and confirmatory test for primary aldosteronism
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation
Time Frame: Baseline
Pulse wave velocity
Baseline
Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation.
Time Frame: Baseline
Left ventricular global longitudinal strain (GLS) measured by transthoracic echocardiography
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4418/26/01/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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