Iron in Patients With Cardiovascular Disease

NCT ID: NCT03991000

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2021-12-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous iron

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.

Group Type: EXPERIMENTAL

Ferric carboxymaltose

Intervention Type: DRUG

Intravenous iron

Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline application according to dosing rules of iron.

Interventions

Ferric carboxymaltose

Intravenous iron

Intervention Type: DRUG

Saline

Saline application according to dosing rules of iron.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. med. Mahir Karakas

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Mahir Karakas

Coordinating Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mahir Karakas, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University Heart Center Hamburg

Locations

University of Berlin, Campus Benjamin-Franklin

Berlin, , Germany

University Heart Center Hamburg

Hamburg, , Germany

University of Ulm

Ulm, , Germany

Countries

Germany

Other Identifiers

iCHF-2

Identifier Type: -

Identifier Source: org_study_id