Iron in Patients With Cardiovascular Disease

Phase 3

Terminated

• Conditions: Atrial Fibrillation; Cardiovascular Diseases; Anemia, Iron-deficiency; Acute Myocardial Infarction; Systolic Heart Failure
• Interventions: Drug: Ferric carboxymaltose; Drug: Saline

• Registration Number: NCT03991000
• Lead Sponsor: Dr. med. Mahir Karakas

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.

Study Timeline

• Study Start: 2019-02-28
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-19
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous iron	Ferric carboxymaltose	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.
Placebo	Saline	Administration of i.v. NaCl according to the dosing rules for intravenous iron.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

University of Ulm; 🇩🇪 Ulm, Germany

University of Berlin, Campus Benjamin-Franklin; 🇩🇪 Berlin, Germany

University Heart Center Hamburg; 🇩🇪 Hamburg, Germany