Atrial FibrillationERETRIANCT05973604
Prevalence of Primary Aldosteronism in Atrial Fibrillation
An observational study of Atrial Fibrillation and Primary Aldosteronism, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This is an observational prospective cross-sectional study, investigating the prevalence of primary aldosteronism in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Primary Aldosteronism
- What is being tested?
- Screening and Confirmatory diagnostic test for primary aldosteronism
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2021to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation
Who may be able to join
- Established diagnosis of atrial fibrillation with a standard surface ECG tracing of at least 30 seconds (either paroxysmal or persistent or permanent).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Ippokratio General Hospital
Thessaloniki, 54642
Maria Toumpourleka, MSc, 00302310892343, m.toumpourleka@gmail.com
Maria Toumpourleka, MSc
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation, Primary Aldosteronism
- Being tested
- Screening and Confirmatory diagnostic test for primary aldosteronism
- Keywords
- Atrial Fibrillation, Primary Aldosteronism
- Medical subject headings
- Atrial Fibrillation, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and Confirmatory diagnostic test for primary aldosteronismDiagnostic 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of primary aldosteronism in patients with atrial fibrillation
Percentage of patients with positive screening and confirmatory test for primary aldosteronism
Measured: Baseline
Secondary outcomes (2)
Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation
Pulse wave velocity
Measured: Baseline
Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation.
Left ventricular global longitudinal strain (GLS) measured by transthoracic echocardiography
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Sep 2021
- Primary completion1 Sep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Toumpourleka, Aristotle University Of Thessaloniki
- Investigators
- Maria Toumpourleka, MSc, Principal investigator, Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, GreeceVassilios P Vassilikos, PhD, Study director, Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, GreeceMichael Doumas, PhD, Study director, Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, GreeceChristodoulos E Papadoupoulos, Study chair, Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973604
- Sponsor's protocol ID
- 4418/26/01/2021
- Acronym
- ERETRIA
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Primary Aldosteronism in Patients With Atrial Fibrillation (ERETRIA Trial)
- ClinicalTrials.gov ID
- NCT05973604
- Acronym / sponsor ID
- ERETRIA / 4418/26/01/2021
- Conditions
- Atrial Fibrillation, Primary Aldosteronism
- Keywords
- Atrial Fibrillation, Primary Aldosteronism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational prospective cross-sectional study, investigating the prevalence of primary aldosteronism in patients with atrial fibrillation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation
Key inclusion criteria (1 listed)
- Established diagnosis of atrial fibrillation with a standard surface ECG tracing of at least 30 seconds (either paroxysmal or persistent or permanent).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening and Confirmatory diagnostic test for primary aldosteronismScreening 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). | Diagnostic test | – |
Primary outcome
Prevalence of primary aldosteronism in patients with atrial fibrillation
Time frame: Baseline
Percentage of patients with positive screening and confirmatory test for primary aldosteronism
2 secondary outcomes
Association of marker of arterial stiffness with presence of primary aldosteronism in patients with atrial fibrillation
Time frame: Baseline
Association of echocardiographic indices with presence of primary aldosteronism in patients with atrial fibrillation.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Toumpourleka, MSc principal investigator
Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
Vassilios P Vassilikos, PhD study director
Third Cardiology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece
Michael Doumas, PhD study director
Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Primary Aldosteronism, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Toumpourleka, MSc (00302310892343, m.toumpourleka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of primary aldosteronism in patients with atrial fibrillation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.