Acute Myocardial Infarction, Anemia, Iron-deficiency, Atrial Fibrillation, Cardiovascular Diseases, Systolic Heart Failure
Conditions
Keywords
Iron deficiency, Atrial fibrillation, Acute myocardial infarction, Systolic heart failure, Anemia
Brief summary
It is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome.
Detailed description
The clinical trial is designed as a prospective, multi-centre, double-blind, randomised, controlled, interventional trial to investigate whether a therapy with i.v. iron (iron carboxymaltose) compared to saline can improve functional status across a subset of cardiovascular disease -namely acute myocardial infarction, atrial fibrillation, and heart failure with reduced ejection fraction. Iron administration will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg iron carboxymaltose (over 15 minutes), except when haemoglobin is \> 16.0 g/dL or ferritin is \> 600 µg/L.
Interventions
DRUGFerric carboxymaltose
Intravenous iron
DRUGSaline
Saline application according to dosing rules of iron.
Sponsors
Dr. med. Mahir Karakas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Cohort A (acute myocardial infarction): Acute Myocardial Infarction within 10 days (randomization/ first iron supplementation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF ≤ 45%) Cohort B (atrial fibrillation): Paroxysmal Atrial fibrillation or persistent AF Cohort C (heart failure): Left-ventricular ejection fraction ≤ 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed 2. Confirmed presence of iron deficiency (ferritin \< 100 ng/mL or ferritin 100 - 299 ng/mL with transferrin saturation \< 20 %) 3. Haemoglobin ≤ 15.5 g/dL 4. Written informed consent
Exclusion criteria
1. Evidence of iron overload or disturbances in the utilisation of iron 2. History of severe asthma, eczema or other atopic allergy 3. History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) 4. Use of renal replacement therapy 5. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort A: Left-ventricular ejection fraction | 16 weeks | Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI |
| Cohort B: Burden of atrial fibrillation | 12 months | Delta between treatment groups in burden of atrial fibrillation from day 90 to 365 as assessed by a routinely implanted event recorder. |
| Cohort C: Left-ventricular ejection fraction | 16 weeks | Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI. |
Countries
Germany
Outcome results
None listed