Iron in Patients With Cardiovascular Disease (iCHF-2)

Dr. med. Mahir Karakas

Status and phase: Terminated; Phase 3

Conditions: Atrial Fibrillation; Systolic Heart Failure; Cardiovascular Diseases; Acute Myocardial Infarction; Anemia, Iron-deficiency

Treatments: Drug: Saline; Drug: Ferric carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT03991000

iCHF-2

Details and patient eligibility

About

It is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Intravenous iron

Experimental group

Description:

Intravenous iron administration in the form of ferric carboxymaltose 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 ferric carboxymaltose at months 4 and 8, except when haemoglobin is \> 16.0 g/dL or ferritin is \> 600 µg/L. To avoid unblinding in these patients a saline infusion will be administered.

Treatment:

Drug: Ferric carboxymaltose

Placebo

Placebo Comparator group

Description:

Administration of i.v. NaCl according to the dosing rules for intravenous iron.

Treatment:

Drug: Saline