Iron-deficiencyAID-AFNCT03957187
Prevalence and Clinical Associates of Iron Deficiency in Patients With Atrial Fibrillation
An observational study of Iron-deficiency and Atrial Fibrillation, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
To estimate the prevalence of iron deficiency (ID) in patients with atrial fibrillation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron-deficiency, Atrial Fibrillation
- What is being tested?
- Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurement
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation
Who may be able to join
- Patients with paroxysmal, persistent and permanent non-valvular atrial fibrillation
- Men and women aged over 18 years
- Left ventricular ejection fraction >0.50
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koc University
Istanbul
Dilek Ural, Prof.
About this study
Official title: 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
Read the 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.
- Conditions
- Iron-deficiency, Atrial Fibrillation
- Being tested
- Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurement
- Keywords
- iron deficiency, atrial fibrillation
- Medical subject headings
- Anemia, Iron-Deficiency, Atrial Fibrillation, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurementDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of iron deficiency in patients with atrial fibrillation
To estimate the prevalence of iron deficiency in patients with atrial fibrillation
Measured: At enrollment
Secondary outcomes (5)
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.
Measured: 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
Measured: At enrollment
Assessment of the relation of iron deficiency to thromboembolic risk score
Thromboembolic risks will be assessed using CHADSVASC score
Measured: At enrollment
Assessment of the relation of iron deficiency to bleeding risk score
Bleeding risks will be assessed using HASBLED score
Measured: 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
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Oct 2019
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma, Abdi Ibrahim Ilac San. ve Tic A.S.
- Responsible party
- Sponsor
- Investigators
- Dilek Ural, Prof., Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957187
- Sponsor's protocol ID
- AID-AF 2019
- Acronym
- AID-AF
- Status last verified
- Apr 2021
- First submitted
- 28 Mar 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Associates of Iron Deficiency in Patients With Atrial Fibrillation (AID-AF)
- ClinicalTrials.gov ID
- NCT03957187
- Acronym / sponsor ID
- AID-AF / AID-AF 2019
- Conditions
- Iron-deficiency, Atrial Fibrillation
- Keywords
- iron deficiency, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Vifor Pharma, Abdi Ibrahim Ilac San. ve Tic A.S.
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation
Key inclusion criteria (3 listed)
- Patients with paroxysmal, persistent and permanent non-valvular atrial fibrillation
- Men and women aged over 18 years
- Left ventricular ejection fraction >0.50
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurementFerritin, 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. | Diagnostic test | – |
Primary outcome
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
5 secondary outcomes
Assessment of the prevalence of iron deficiency in patients with paroxysmal, persistent and permanent atrial fibrillation
Time frame: At enrollment
Assessment of the relation of iron deficiency to functional capacity
Time frame: At enrollment
Assessment of the relation of iron deficiency to thromboembolic risk score
Time frame: At enrollment
Assessment of the relation of iron deficiency to bleeding risk score
Time frame: At enrollment
Assessment of the relation of iron deficiency to hs-CRP level
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Ural, Prof. principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron-deficiency and Atrial Fibrillation, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Ural, Prof. (+90 212 338 10 00, dural@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of iron deficiency in patients with atrial fibrillation (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.