Clinical trial NCT03957187: Prevalence and Clinical Associates of Iron Deficiency in Patients With Atrial Fibrillation
Official title: Prevalence and Clinical Associates of Iron Deficiency in Patients With Atrial Fibrillation (AID-AF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron-deficiency
Atrial Fibrillation
Keywords: iron deficiency
atrial fibrillation
Lead sponsor: Koç University
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
name: Abdi Ibrahim Ilac San. ve Tic A.S.
First posted: 2019-05-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation

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

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Prevalence of iron deficiency in patients with atrial fibrillation
timeFrame: At enrollment
Secondary outcomes:
measure: Assessment of the prevalence of iron deficiency in patients with paroxysmal, persistent and permanent atrial fibrillation
timeFrame: At enrollment
measure: Assessment of the relation of iron deficiency to functional capacity
timeFrame: At enrollment
measure: Assessment of the relation of iron deficiency to thromboembolic risk score
timeFrame: At enrollment
measure: Assessment of the relation of iron deficiency to bleeding risk score
timeFrame: At enrollment
measure: Assessment of the relation of iron deficiency to hs-CRP level
timeFrame: At enrollment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Dilek Ural, Prof.
role: PRINCIPAL_INVESTIGATOR
References: