Iron in Patients With Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

— iCHF-2  

Official title:

Investigator-initiated, Randomized, Double-blind, Controlled, Multi-center Trial of Intravenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03991000
• Other study ID #: iCHF-2
• Status: Terminated
• Phase: Phase 3
• Start date: February 28, 2019
• Est. completion date: December 15, 2021

Study information

• Verified date: December 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ferric carboxymaltose
Intravenous iron
• Saline
Saline application according to dosing rules of iron.

Locations

Country	Name	City	State
Germany	University of Berlin, Campus Benjamin-Franklin	Berlin
Germany	University Heart Center Hamburg	Hamburg
Germany	University of Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Dr. med. Mahir Karakas

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort A: Left-ventricular ejection fraction	Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI	16 weeks
Primary	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
Primary	Cohort C: Left-ventricular ejection fraction	Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI.	16 weeks