iCHF-2: Iron in Patients With Cardiovascular Disease

Sponsor
Dr. med. Mahir Karakas (Other)
Overall Status
Recruiting
CT.gov ID
NCT03991000
Collaborator
(none)
480
3
2
51.1
160
3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
480 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigator-initiated, Randomized, Double-blind, Controlled, Multi-center Trial of Intravenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency
Actual Study Start Date :
Feb 28, 2019
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Ferric carboxymaltose
Intravenous iron

Placebo Comparator: Placebo

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

Drug: Saline
Saline application according to dosing rules of iron.

Outcome Measures

Primary Outcome Measures

  1. Cohort A: Left-ventricular ejection fraction [16 weeks]

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

  2. 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.

  3. Cohort C: Left-ventricular ejection fraction [16 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Berlin, Campus Benjamin-Franklin Berlin Germany 12203
2 University Heart Center Hamburg Hamburg Germany 20246
3 University of Ulm Ulm Germany 89081

Sponsors and Collaborators

  • Dr. med. Mahir Karakas

Investigators

  • Principal Investigator: Mahir Karakas, MD, MBA, University Heart Center Hamburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. med. Mahir Karakas, Coordinating Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT03991000
Other Study ID Numbers:
  • iCHF-2
First Posted:
Jun 19, 2019
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. med. Mahir Karakas, Coordinating Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021