Effect of Iron Repletion in Symptomatic Patients with Atrial Fibrillation (IRON-AF)

Phase 4

Recruiting

• Conditions: Atrial fibrillation; Iron deficiency; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12620000285954
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-03
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

•At least 18 years of age
•Paroxysmal or persistent atrial fibrillation
•Stable medical therapy in the 4 weeks prior to enrolment with no dose changes of atrial fibrillation drugs in the last 2 weeks
•Haemoglobin < 150g/L
•Serum ferritin < 100 ug/L or serum ferritin < 300 ug/L if Tsat < 20%

Exclusion Criteria

• Known hypersensitivity to parenteral iron preparations
• History of primary or secondary haemochromatosis
• Known haemoglobinopathy or haemolytic anaemia
• History of erythropoietin-stimulating agent, intravenous iron therapy, and / or blood transfusion in the 6 weeks prior to randomisation
• Requiring treatment with blood transfusion in the next 3 months
• Requiring surgery with anticipated moderate or severe blood loss in the next 3 months
• Oral iron therapy at doses > 80 mg/day (of elemental iron) in the 1 week prior to randomisation (note: ongoing use of multivitamins containing <= 80 mg/day is permitted)
• Planned cardioversion, catheter ablation, AV nodal ablation with pacemaker insertion or surgical ablation within the next 3 months
• Body weight <= 35 kg
• Exercise training program(s) in the 3 months prior to screening, or planned in the next 3 months
• Ongoing blood loss
• Current active autoimmune or systemic inflammatory diseases
• Current active systemic infection or bacteraemia
• Known chronic liver disease, hepatitis B or hepatitis C infection, or screening AST / ALT above three times the upper limit of normal range
• Known active malignancy, with the exception of squamous cell and basal cell carcinoma of the skin, and cervical intraepithelial neoplasia
• Currently receiving systemic chemotherapy and/or radiotherapy
• Known chronic kidney disease
• History of dialysis, current dialysis or dialysis planned within the next 3 months
• Currently pregnant, breastfeeding, or trying to conceive within the next 3 months
• Acute myocardial infarction, transient ischaemic attack, or stroke in the 3 months prior to randomisation
• Coronary artery bypass graft, percutaneous intervention, or major surgery (including thoracic and cardiac surgery) within the last 3 months (diagnostic catheterisations are allowed)
• Subject is unable to perform exercise testing, either according to the Investigator’s judgement, or due to the following conditions:
o Severe lower limb musculoskeletal or neurological conditions
o Unstable angina
o Severe valvular or left ventricular outflow tract obstruction requiring intervention
• Subject is currently enrolled in, or is within 30 days of completion of, another interventional study
• Subject has previously been randomised to this study (subjects may be rescreened if they previously did not meet the eligibility criteria)
• Subject will not be available for completion of all assessments as per the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VO2 peak (mL/min/kg) as assessed by cardiopulmonary exercise testing (CPET) performed on a cycle ergometer using a metabolic chart.<br>Change in ventilatory efficiency, as assessed by cardiopulmonary exercise testing (CPET) performed on a cycle ergometer.[12 weeks post baseline ]