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出境医 / 临床实验 / Iron in Patients With Cardiovascular Disease (iCHF-2)

Iron in Patients With Cardiovascular Disease (iCHF-2)

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
Cardiovascular Diseases Anemia, Iron-deficiency Acute Myocardial Infarction Atrial Fibrillation Systolic Heart Failure Drug: Ferric carboxymaltose Drug: Saline 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 Intrvenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 16 weeks ]
    Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Mahir Karakas, MD, MBA +4915222817493 m.karakas@uke.de

Locations
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Germany
University of Berlin, Campus Benjamin-Franklin Not yet recruiting
Berlin, Germany, 12203
Contact: Ulf Landmesser, MD         
University Heart Center Hamburg Recruiting
Hamburg, Germany, 20246
Contact: Mahir Karakas, MD, MBA    +4915222817493    m.karakas@uke.de   
University of Ulm Not yet recruiting
Ulm, Germany, 89081
Contact: Sinisa Markovic, MD         
Sponsors and Collaborators
Dr. med. Mahir Karakas
Investigators
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Principal Investigator: Mahir Karakas, MD, MBA University Heart Center Hamburg
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Cohort A: Left-ventricular ejection fraction [ Time Frame: 16 weeks ]
    Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI
  • Cohort B: Burden of atrial fibrillation [ Time Frame: 12 months ]
    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 [ Time Frame: 16 weeks ]
    Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iron in Patients With Cardiovascular Disease
Official Title  ICMJE Investigator-initiated, Randomized, Double-blind, Controlled, Multi-center Trial of Intrvenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Anemia, Iron-deficiency
  • Acute Myocardial Infarction
  • Atrial Fibrillation
  • Systolic Heart Failure
Intervention  ICMJE
  • Drug: Ferric carboxymaltose
    Intravenous iron
  • Drug: Saline
    Saline application according to dosing rules of iron.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ferric carboxymaltose
  • Placebo Comparator: Placebo
    Administration of i.v. NaCl according to the dosing rules for intravenous iron.
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mahir Karakas, MD, MBA +4915222817493 m.karakas@uke.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991000
Other Study ID Numbers  ICMJE iCHF-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Dr. med. Mahir Karakas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mahir Karakas, MD, MBA University Heart Center Hamburg
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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