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

NCT03957187 | Unknown

• 1 other identifier: AID-AF 2019
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron-deficiency; Atrial Fibrillation

Keywords

iron deficiency; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Prevalence of iron deficiency in patients with atrial fibrillation

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

  At enrollment

Secondary Outcomes (5)

• Assessment of the prevalence of iron deficiency in patients with paroxysmal, persistent and permanent atrial fibrillation

  At enrollment

• Assessment of the relation of iron deficiency to functional capacity

  At enrollment

• Assessment of the relation of iron deficiency to thromboembolic risk score

  At enrollment

• Assessment of the relation of iron deficiency to bleeding risk score

  At enrollment

• Assessment of the relation of iron deficiency to hs-CRP level

  At enrollment

Interventions

Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurement DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead
• Vifor Pharma: collaborator
• Abdi Ibrahim Ilac San. ve Tic A.S.: collaborator

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Atrial Fibrillation; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Ural, Prof.

  Koç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Ural, Prof.

CONTACT

+90 212 338 10 00; dural@ku.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: May 21, 2019
• Study Start: October 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 14, 2022

Record last verified: 2021-04

Locations

TU (1)