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Iron in Patients With Cardiovascular Disease (iCHF-2)

Primary Purpose

Cardiovascular Diseases, Anemia, Iron-deficiency, Acute Myocardial Infarction

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Ferric carboxymaltose
Saline
Sponsored by
Dr. med. Mahir Karakas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Iron deficiency, Atrial fibrillation, Acute myocardial infarction, Systolic heart failure, Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Berlin, Campus Benjamin-Franklin
  • University Heart Center HamburgRecruiting
  • University of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous iron

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Cohort A: Left-ventricular ejection fraction
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI
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.
Cohort C: Left-ventricular ejection fraction
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2019
Last Updated
October 7, 2021
Sponsor
Dr. med. Mahir Karakas
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1. Study Identification

Unique Protocol Identification Number
NCT03991000
Brief Title
Iron in Patients With Cardiovascular Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. med. Mahir Karakas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous iron
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administration of i.v. NaCl according to the dosing rules for intravenous iron.
Intervention Type
Drug
Intervention Name(s)
Ferric carboxymaltose
Intervention Description
Intravenous iron
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline application according to dosing rules of iron.
Primary Outcome Measure Information:
Title
Cohort A: Left-ventricular ejection fraction
Description
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI
Time Frame
16 weeks
Title
Cohort B: Burden of atrial fibrillation
Description
Delta between treatment groups in burden of atrial fibrillation from day 90 to 365 as assessed by a routinely implanted event recorder.
Time Frame
12 months
Title
Cohort C: Left-ventricular ejection fraction
Description
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahir Karakas, MD, MBA
Phone
+4915222817493
Email
m.karakas@uke.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahir Karakas, MD, MBA
Organizational Affiliation
University Heart Center Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Berlin, Campus Benjamin-Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulf Landmesser, MD
Facility Name
University Heart Center Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahir Karakas, MD, MBA
Phone
+4915222817493
Email
m.karakas@uke.de
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinisa Markovic, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Iron in Patients With Cardiovascular Disease

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