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Trial record 14 of 380 for:    FERRIC CATION

Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy (IRON-CRT)

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ClinicalTrials.gov Identifier: NCT03380520
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
Ziekenhuis Oost-Limburg
Information provided by (Responsible Party):
Wilfried Mullens, MD PhD, Hasselt University

Brief Summary:
To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Ferric Carboxymaltose Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Experimental: Ferric carboxymaltose
Ferric carboxymaltose according to SmPC
Drug: Ferric Carboxymaltose
Ferric carboxymaltose will be administered according to product specification dosing
Other Name: injectafer

Placebo Comparator: Placebo
Normal saline (0.9%)
Drug: Placebo
IV nacl 0.9%




Primary Outcome Measures :
  1. Change in left ventricular ejection fraction from baseline [ Time Frame: 3 months ]
    delta_LVEF measured by 3D-echocardiography


Secondary Outcome Measures :
  1. Change in left ventricular end systolic volume from baseline [ Time Frame: 3 months ]
    delta_LVESV measured by 3D-echocardiography

  2. Change in left ventricular end diastolic volume from baseline [ Time Frame: 3 months ]
    delta_LVEDV measured by 3D-echocardiography

  3. Force frequency relationship [ Time Frame: 3 months ]
    measured by 2D-echocardiography

  4. Heart failure hospitalization and all-cause mortality [ Time Frame: Up to six months ]
    measured by telephone contact

  5. Incidence of Treatment-associated Serious and non-serious adverse events. [ Time Frame: During intravenous study drug administration and 1-hour in hospital follow-up ]
    Serious and non-serious adverse events (AE) will be registered, which include:start date AE, duration AE, end-date AE, treatment group, continuation of AE after dose interruption, causality with study medication, presence of risk factors for AE and response to AE (sequela or recovery).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin < 100 μg/l, irrespective of TSAT or ferritine between 100 - 300 μg/l with TSAT < 20%) and presence of incomplete reverse remodeling (LVEF < 40%).
  2. Age ≥18 years
  3. Obtained informed consent
  4. Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)

Exclusion Criteria:

  1. Hemochromatosis, iron overload, defined as TSAT > 45%
  2. Hemoglobin > 15 g/dl at inclusion
  3. Known hypersensitivity to injectafer®.
  4. Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.
  5. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
  6. Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
  7. History of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
  8. Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
  9. Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months.
  10. Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
  11. Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
  12. Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).
  13. Pregnancy or lactation.
  14. Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
  15. Planned cardiac hospitalization during study follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380520


Contacts
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Contact: Pieter Martens, MD 003289321516 pieter_martens2@zol.be
Contact: Wilfried Mullens, MD PhD 003289327078 wilfried.mullens@zol.be

Locations
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Belgium
Pieter Martens Recruiting
Genk, Limburg, Belgium, 3500
Contact: Pieter Martens, MD    003289321516    pieter_martens2@zol.be   
Sponsors and Collaborators
Hasselt University
Ziekenhuis Oost-Limburg

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Responsible Party: Wilfried Mullens, MD PhD, Md PhD, Hasselt University
ClinicalTrials.gov Identifier: NCT03380520     History of Changes
Other Study ID Numbers: IRON-CRT
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Yes, full patient level data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Ferric Compounds
Hematinics