免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / 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)

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

Condition or disease Intervention/treatment
Iron-deficiency Atrial Fibrillation 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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence and Clinical Associates of Iron Deficiency in Patients With Atrial Fibrillation (AID-AF)
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Prevalence of iron deficiency in patients with atrial fibrillation [ Time Frame: At enrollment ]
    To estimate the prevalence of iron deficiency in patients with atrial fibrillation


Secondary Outcome Measures :
  1. Assessment of the prevalence of iron deficiency in patients with paroxysmal, persistent and permanent atrial fibrillation [ Time Frame: At enrollment ]
    To estimate the prevalence of iron deficiency in patients with paroxysmal, persistent and permanent atrial fibrillation at enrollment.

  2. Assessment of the relation of iron deficiency to functional capacity [ Time Frame: At enrollment ]
    The functional capacity of the patients will be assessed with 6-minute walk test

  3. Assessment of the relation of iron deficiency to thromboembolic risk score [ Time Frame: At enrollment ]
    Thromboembolic risks will be assessed using CHADSVASC score

  4. Assessment of the relation of iron deficiency to bleeding risk score [ Time Frame: At enrollment ]
    Bleeding risks will be assessed using HASBLED score

  5. Assessment of the relation of iron deficiency to hs-CRP level [ Time Frame: At enrollment ]
    hs-CRP level (milligram/Liter) will be measured in patients with paroxysmal, persistent and permanent atrial fibrillation at enrollment


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date March 28, 2019
First Posted Date May 21, 2019
Last Update Posted Date April 23, 2021
Actual Study Start Date October 1, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2019)
Prevalence of iron deficiency in patients with atrial fibrillation [ Time Frame: At enrollment ]
To estimate the prevalence of iron deficiency in patients with atrial fibrillation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 18, 2019)
  • Assessment of the prevalence of iron deficiency in patients with paroxysmal, persistent and permanent atrial fibrillation [ Time Frame: At enrollment ]
    To estimate 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 [ Time Frame: At enrollment ]
    The functional capacity of the patients will be assessed with 6-minute walk test
  • Assessment of the relation of iron deficiency to thromboembolic risk score [ Time Frame: At enrollment ]
    Thromboembolic risks will be assessed using CHADSVASC score
  • Assessment of the relation of iron deficiency to bleeding risk score [ Time Frame: At enrollment ]
    Bleeding risks will be assessed using HASBLED score
  • Assessment of the relation of iron deficiency to hs-CRP level [ Time Frame: At enrollment ]
    hs-CRP level (milligram/Liter) will be measured in patients with paroxysmal, persistent and permanent atrial fibrillation at enrollment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with atrial fibrillation
Condition
  • Iron-deficiency
  • Atrial Fibrillation
Intervention Diagnostic Test: Ferritin, 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.

Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 18, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Dilek Ural, Prof. +90 212 338 10 00 dural@ku.edu.tr
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03957187
Other Study ID Numbers AID-AF 2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Koç University
Study Sponsor Koç University
Collaborators
  • Vifor (International) Inc.
  • Abdi Ibrahim Ilac San. ve Tic A.S.
Investigators
Principal Investigator: Dilek Ural, Prof. Koç University
PRS Account Koç University
Verification Date April 2021