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

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

Study Overview

• Status: Recruiting
• Conditions: Iron-deficiency; Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurement

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Dilek Ural, Prof.; Phone Number: +90 212 338 10 00; Email: dural@ku.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Koç University
    • Contact: Dilek Ural, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of iron deficiency in patients with atrial fibrillation	To estimate the prevalence of iron deficiency in patients with atrial fibrillation	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	At enrollment
Assessment of the relation of iron deficiency to thromboembolic risk score	Thromboembolic risks will be assessed using CHADSVASC score	At enrollment
Assessment of the relation of iron deficiency to bleeding risk score	Bleeding risks will be assessed using HASBLED score	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	At enrollment

Collaborators and Investigators

• Sponsor: Koç University
• Collaborators: Vifor Pharma; Abdi Ibrahim Ilac San. ve Tic A.S.
• Investigators: Principal Investigator: Dilek Ural, Prof., Koç University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: May 18, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: atrial fibrillation; iron deficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Arrhythmias, Cardiac; Anemia, Iron-Deficiency; Atrial Fibrillation
• Other Study ID Numbers: AID-AF 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No