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
To estimate the prevalence of iron deficiency (ID) in patients with atrial fibrillation
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.
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 →Koç University is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
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Patients with atrial fibrillation
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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.
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
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
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
Assessment of the relation of iron deficiency to thromboembolic risk score
Thromboembolic risks will be assessed using CHADSVASC score
Time frame: At enrollment
Assessment of the relation of iron deficiency to bleeding risk score
Bleeding risks will be assessed using HASBLED score
Time frame: At enrollment
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
Plan to share: Undecided
No publications or documents are linked to this record.
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.
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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