Iron in Patients With Cardiovascular Disease

NCT03991000 | Terminated Phase 3 DMC

• 1 other identifier: iCHF-2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Keywords

Iron deficiency; Atrial fibrillation; Acute myocardial infarction; Systolic heart failure; Anemia

Outcome Measures

Primary Outcomes (3)

• Cohort A: Left-ventricular ejection fraction

  Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI

  16 weeks

• Cohort B: Burden of atrial fibrillation

  Delta between treatment groups in burden of atrial fibrillation from day 90 to 365 as assessed by a routinely implanted event recorder.

  12 months

• Cohort C: Left-ventricular ejection fraction

  Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI.

  16 weeks

Study Arms (2)

Intravenous iron

EXPERIMENTAL

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.

Drug: Ferric carboxymaltose

Placebo

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Ferric carboxymaltose DRUG

Intravenous iron

Intravenous iron

Saline DRUG

Saline application according to dosing rules of iron.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Confirmed presence of iron deficiency (ferritin \< 100 ng/mL or ferritin 100 - 299 ng/mL with transferrin saturation \< 20 %)
• Haemoglobin ≤ 15.5 g/dL
• Written informed consent

You may not qualify if:

• Evidence of iron overload or disturbances in the utilisation of iron
• History of severe asthma, eczema or other atopic allergy
• History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
• Use of renal replacement therapy
• Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.

Sponsors & Collaborators

• Dr. med. Mahir Karakas: lead

Study Sites (3)

University of Berlin, Campus Benjamin-Franklin

Berlin, 12203, Germany

Location

University Heart Center Hamburg

Hamburg, 20246, Germany

Location

University of Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Anemia, Iron-Deficiency; Atrial Fibrillation; Heart Failure, Systolic; Iron Deficiencies; Anemia

Interventions

ferric carboxymaltose; Sodium Chloride

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Failure

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mahir Karakas, MD, MBA

  University Heart Center Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: February 28, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)