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Status unknownNCT03957187AID-AFUpdated Mar 14, 2022

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

An observational study in Iron-deficiency and Atrial Fibrillation, sponsored by Koç University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-14.

Sponsored by Koç University · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Iron-deficiency
  • Atrial Fibrillation

Keywords

  • iron deficiency
  • atrial fibrillation
03

In context

Anemia, Iron-Deficiency

660 studies on the registry are indexed under Anemia, Iron-Deficiency; 106 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 117 observational studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Koç University is the lead sponsor of 109 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with atrial fibrillation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testFerritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurement

    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.

06

What researchers measure

Primary outcomes

  1. Prevalence of iron deficiency in patients with atrial fibrillation

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

    Time frame: At enrollment

Secondary outcomes

  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.

    Time frame: 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

    Time frame: At enrollment

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

    Thromboembolic risks will be assessed using CHADSVASC score

    Time frame: At enrollment

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

    Bleeding risks will be assessed using HASBLED score

    Time frame: 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

    Time frame: At enrollment

07

Study locations

1 of 1 sites recruiting
  • Koc University
    Istanbul, Turkey (Türkiye)
    • Dilek Ural, Prof. · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2019 (actual). Primary completion is estimated for Jun 2022, 32 months after the start.

Of 47 non-industry observational studies under Anemia, Iron-Deficiency, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 32 months is above that.

Counting every sponsor, half of 52 studies reached it within 27 months; a quarter within 12 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2019
First posted
May 21, 2019
StartActual
Oct 1, 2019
Primary completionEst.
Jun 2022
CompletionEst.
Aug 2022
Last update
Mar 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03957187
Lead sponsor
Koç University
Collaborators
Vifor Pharma, Abdi Ibrahim Ilac San. ve Tic A.S.
Responsible party
Sponsor
First posted
May 21, 2019
Start date
Oct 1, 2019
Primary completion
Jun 2022 (estimated)
Completion
Aug 2022 (estimated)
Last update
Mar 14, 2022

Study contacts

Dilek Ural, Prof.
Contact
dural@ku.edu.tr
+90 212 338 10 00
Dilek Ural, Prof.
principal investigator · Koç University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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