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Iron-deficiencyAID-AFNCT03957187

Prevalence and Clinical Associates of Iron Deficiency in Patients With Atrial Fibrillation

An observational study of Iron-deficiency and Atrial Fibrillation, run by Koç University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To estimate the prevalence of iron deficiency (ID) in patients with atrial fibrillation Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Iron-deficiency, Atrial Fibrillation
What is being tested?
Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurement
How many people
1,000 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2019to Aug 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with atrial fibrillation

Who may be able to join

  • Patients with paroxysmal, persistent and permanent non-valvular atrial fibrillation
  • Men and women aged over 18 years
  • Left ventricular ejection fraction >0.50

Who cannot join

  • Left ventricular ejection fraction <0.50
  • Patients with overt symptoms and signs of heart failure
  • Patients with a known chronic inflammatory disease
  • Patients with hemodynamically significant valvular heart disease
  • Patients who had received management for iron deficiency in the preceding 12 months

Trial locations and contacts

1 site in 1 country.

Dilek Ural, Prof. contact

+90 212 338 10 00

dural@ku.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Koc University

    Istanbul

    Dilek Ural, Prof.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Prevalence and Clinical Associates of Iron Deficiency in Patients With Atrial Fibrillation (AID-AF)

To estimate the prevalence of iron deficiency (ID) in patients with atrial fibrillation

Read the detailed description

Atrial fibrillation is the most frequent chronic arrhythmia with an increasing prevalence in developed and developing countries. Estimated number of individuals living with chronic atrial fibrillation is 33 million globally. In developed and developing countries, the number of elderly individuals increases steadily and the incidence varies from 0.21 to 0.41/1000 person-years depending on regional differences. Approximately half of atrial fibrillation cases are permanent (chronic), 25% are paroxysmal (ending within one week), and 25% are persistant atrial fibrillation (ending for a week, spontaneous or intervention).

Symptoms and signs of atrial fibrillation vary between individuals, and the clinical picture appears in a wide range of conditions ranging from asymptomatic events to thromboembolic events or patients with severe heart failure. The most common symptoms are; palpitations, fatigue, exercise intolerance, and systemic thromboembolic events in patients who do not receive appropriate anticoagulant treatment. Long-term follow-up, especially in persistent and permanent atrial fibrillation patients results in preserved ejection fraction heart failure and right heart failure. Prevention of thromboembolic events is the most important approach. Patients with paroxysmal, persistent and permanent atrial fibrillation have to take life-long oral anticoagulation therapy if they are at high risk for developing thromboembolic events. In patients with oral anticoagulant therapy, the risk of bleeding increases and hemorrhagic events are seen, ranging from life threatening asymptomatic blood loss to lethal cerebral hemorrhage.

Atrial fibrillation is considered as a chronic inflammatory disease. Both in general population and in patients with cardiac diseases, inflammatory mediators can alter atrial electrophysiology and structure, and thereby increase the tendency to develop atrial fibrillation. Enormous number of studies showed a clear association between inflammatory markers and thromboembolic events in atrial fibrillation.

Anemia is a frequently encountered problem in atrial fibrillation patients with a prevalence of 12.3%. Existing studies suggested an association between anemia and thromboembolic events in atrial fibrillation. However, current evidence supports that it is a marker for increased risk of bleeding after anticoagulant therapy, and two bleeding risk scores (ATRIA and HEAMORRHAGES) included presence of anemia as a component of risk assessment.

Despite of a clear association between anemia and unfavorable events in atrial fibrillation, none of the studies determined the type anemia in these patients so far. In a preliminary single center study, with relatively limited number of cases (n = 101), it is shown that 47.6% of patients with atrial fibrillation had ID according to the criteria used for heart failure patients. B12 (9.9%) and folic acid (12.9%) deficiencies were less frequent Again in the same study, the prevalence of ID was found to be twice as frequent as the paroxysmal atrial fibrillation group in the permanent atrial fibrillation group, suggesting that ID is associated with high sensitive C-reactive protein and N-terminal proBNP levels. The validation of this study findings in a larger, non-retrospective case-group and the clinical determinants of ID in patients with atrial fibrillation will be useful in the clinical evaluation of patients and in planning possible treatment alternatives.

Being tested
Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurement
Keywords
iron deficiency, atrial fibrillation
Medical subject headings
Anemia, Iron-Deficiency, Atrial Fibrillation, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurementDiagnostic test

    Ferritin, iron and iron binding capacity will be measured for evaluation of ID using Cobas c-e and Elecsys.

    The relation of inflammation to iron deficiency will be evaluated by high sensitive C-reactive protein measurement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of iron deficiency in patients with atrial fibrillation

    To estimate the prevalence of iron deficiency in patients with atrial fibrillation

    Measured: At enrollment

Secondary outcomes (5)
  1. Assessment of the prevalence of iron deficiency in patients with paroxysmal, persistent and permanent atrial fibrillation

    To estimate the prevalence of iron deficiency in patients with paroxysmal, persistent and permanent atrial fibrillation at enrollment.

    Measured: At enrollment

  2. Assessment of the relation of iron deficiency to functional capacity

    The functional capacity of the patients will be assessed with 6-minute walk test

    Measured: At enrollment

  3. Assessment of the relation of iron deficiency to thromboembolic risk score

    Thromboembolic risks will be assessed using CHADSVASC score

    Measured: At enrollment

  4. Assessment of the relation of iron deficiency to bleeding risk score

    Bleeding risks will be assessed using HASBLED score

    Measured: At enrollment

  5. Assessment of the relation of iron deficiency to hs-CRP level

    hs-CRP level (milligram/Liter) will be measured in patients with paroxysmal, persistent and permanent atrial fibrillation at enrollment

    Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2019
  2. Study start1 Oct 2019
  3. Primary completionJun 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03957187
Sponsor's protocol ID
AID-AF 2019
Acronym
AID-AF
Status last verified
Apr 2021
First submitted
28 Mar 2019
Last updated
14 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Iron-deficiency and Atrial Fibrillation, run by Koç University at 1 site in Turkey (Türkiye).

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 3 inclusion and 5 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 14 Mar 2022. 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 Turkey (Türkiye). 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 Dilek Ural, Prof. (+90 212 338 10 00, dural@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of iron deficiency in patients with atrial fibrillation (time frame: At enrollment). 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 14 Mar 2022.

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