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Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction (FAIR-HFpEF)

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ClinicalTrials.gov Identifier: NCT03074591
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
University of Göttingen
Information provided by (Responsible Party):
Doehner, W, Charite University, Berlin, Germany

Brief Summary:
This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe

Condition or disease Intervention/treatment Phase
Iron-deficiency Heart Failure Drug: Ferric Carboxymaltose 50Mg/Ml Inj 15Ml Drug: Saline Solution for Injection Phase 2

Detailed Description:
All previous trials have excluded patients with HFpEF. This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe. The FAIR-HFpEF study was designed to evaluate the efficacy of Ferinject® in improving symptoms of HFpEF in patients with ID. Analyses will focus both on subjective and objective measures as well as on patients with and without anaemia. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of IV Iron (Ferric Carboxymaltose, Ferinject) on Exercise Tolerance, Symptoms and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF) and Iron Deficiency With and Without Anaemia.
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment
Active treatment: Ferric Carboxymaltose solution (Ferinject®) for parenteral application, 50 mg/mL iron. Medication will be given as a short time infusion over 15 minutes in 100mL NaCl.
Drug: Ferric Carboxymaltose 50Mg/Ml Inj 15Ml
After baseline assessments patients will be randomised in a 1:1 ratio to receive Ferric Carboxymaltose IV or placebo/saline (normal saline: 0.9% w/v NaCl). In the Treatment group, Ferric Carboxymaltose will be administered according to the dosing schedule.

Placebo Comparator: Placebo
Placebo: Normal saline (0.9% weight/volume (w/v) NaCl) administered in analogy to active treatment procedures.
Drug: Saline Solution for Injection
In the placebo/saline group, patients will receive the aequivalent number of normal saline infusions.




Primary Outcome Measures :
  1. exercise capacity [ Time Frame: 52 weeks ]
    The difference of 6-minute walking distance in meters from baseline to end of study in symptomatic patients with HFpEF with documented ID compared to the control group.


Secondary Outcome Measures :
  1. 6min-walking distance [ Time Frame: 52 weeks ]
    Difference of 6-minute walking distance in meters from baseline end of study in symptomatic patients with HFpEF with documented ID compared to the control group

  2. quality of life [ Time Frame: 52 weeks ]
    Difference in quality of life in symptomatic patients with HFpEF with documented ID from baseline to end of study.

  3. NYHA functional class [ Time Frame: 52 weeks ]
    Difference in NYHA class from baseline to end of study in symptomatic patients with HFpEF

  4. Mortality and Heart failure-related hospitalization rates [ Time Frame: 52 weeks ]
    Effects on mortality and HF-related hospitalization rates in symptomatic patients from baseline to end of study.



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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. Patient is willing to participate and provides written informed consent;
  2. Age ≥18 years;
  3. Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF) with LVEF ≥45% at screening or within 6 months prior to planned randomisation (assessed by echocardiography or MRI);
  4. Ambulatory for at least 7 days with NYHA class II or III at time of randomisation (the screening visit can take place at the end of a hospitalisation);
  5. Treated with a diuretic;
  6. Presence of atrial fibrillation (AF) at screening or randomisation is allowed in 2 out of 4 patients (calculated per centre);
  7. At screening or randomisation, presence of one of the following criteria:

    1. hospitalisation with a diagnosis of HF within 12 months prior to planned randomisation; OR
    2. raised plasma levels of natriuretic peptides in a patient with sinus rhythm (i.e. in patients without AF: NT-proBNP >300 pg/mL or BNP >100 pg/mL or MR-proANP >120 pmol/L; in patients with AF: NT-proBNP >600 pg/mL or BNP >200 pg/mL or MR-proANP >250 pmol/l)
  8. Evidence of diastolic dysfunction at screening or randomisation, defined as:

    1. E/E' >13; OR
    2. LA width ≥38 mm; OR
    3. LA length ≥50 mm; OR
    4. LA area ≥20 cm2; OR
    5. LA volume ≥55 ml; OR
    6. left atrial volume index >28 mL/m2;
  9. Haemoglobin >9.0 g/dL and ≤14.0 g/dL (at screening);
  10. ID with ferritin <100 ng/mL or ferritin 100-299 plus TSAT <20% (at screening);
  11. 6-minute-walking distance at baseline <450 m (average of the last 2 documented tests within 8 weeks prior to planned randomisation that also need to be within 20% of each other).

Exclusion Criteria:

  1. Unable to sign informed consent
  2. Any prior echocardiography measurement of LVEF <40%;
  3. Clinical signs and symptoms of infection including fever >38°C;
  4. Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;
  5. Use of concurrent immunosuppressive therapy;
  6. History of acquired iron overload or haemochromatosis (or a first relative with haemochromatosis);
  7. Known hypersensitivity to FCM or any other IV iron product;
  8. Known bleeding or haemolytic anemia;
  9. Presence of any condition that precludes exercise testing, such as decompensated HF, significant musculoskeletal disease, unstable angina pectoris, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled brady-arrhythmias or tachy-arrhythmias;
  10. Probable alternative diagnoses that in the opiniton of the investigator could account for the patient's HF symptoms such as severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD); hence, patients with the following are excluded:

    1. Severe COPD, i.e. with known FEV1 <50%, requiring home oxygen therapy, or on chronic oral steroid therapy;
    2. body mass index ≥40.0 kg/m2;
  11. Presence of uncontrolled atrial fibrillation with resting heart rate >110/min;
  12. Presence of uncontrolled hypertension with blood pressure >160/100 mm Hg;
  13. Renal replacement therapy;
  14. Concurrent therapy with an erythropoiesis stimulating agent;
  15. Known active malignancy;
  16. Known HIV or active hepatitis infection;
  17. Pregnancy;
  18. Patients, who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
  19. Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial.
  20. Participation in another clinical trial within previous 30 days and/ or anticipated participation in another trial during this study.
  21. Inability to fully comprehend and/or perform study procedures in the investigator's opinion;
  22. Persons staying at an institution due to order by a national body or a court of law.

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): NCT03074591


Contacts
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Contact: Stephan von Haehling, Dr 00495513920911 stephan.von.haehling@med.uni-goettingen.de
Contact: Nicole Ebner, Dr 0049551398132 nicole.ebner@med.uni-goettingen.de

Locations
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Germany
Innere Medizin/Kardiologie Recruiting
Nurnberg, Bavaria, Germany, 90402
Contact: Michael Jeserich, Dr       mjeserich@aol.com   
Herz- und Gefässzentrum Bad Bevensen Recruiting
Bad Bevensen, Lower Saxony, Germany, 29549
Contact: Remppis, Prof       ba.remppis@hgz-bb.de   
Contact: Merle Siems       m.siems@hgz-bb.de   
University Medical Center Göttingen Recruiting
Gottingen, Lower Saxony, Germany, 37075
Contact: Stephan von Haehling, Dr       stephan.von.haehling@med.uni-goettingen.de   
Contact: Nicole Ebner, Dr       nicole.ebner@med.uni-goettingen.de   
Medizinische Hochschule Hannover Klinik für Kardiologie und Angiologie Recruiting
Hannover, Lower Saxony, Germany
Contact: Johann Bauersachs, Prof       Bauersachs.Johann@mh-hannover.de   
Contact: Karin Hohenleitner-Luehrsen, Dr       Hohenleitner-Luehrssen.Karin@mh-hannover.de   
Elbeklinikum Stade Recruiting
Stade, Lower saxony, Germany, 21682
Contact: Sebastian Philipp, Dr       sebastian.philipp@elbekliniken.de   
Contact: Vanessa Philipp       vanessa.philipp@elbekliniken.de   
Katholisches Klinikum Mainz St. Vincenz und Elisabeth Hospital Klinik für Innere Medizin 1 Recruiting
Mainz, Rhineland-Palatinate, Germany, 55116
Contact: Sabine Genth-Zotz, Prof       Innere-Medizin-1@kkmainz.de   
Contact: Bärbel Käsberger       b.kaesberger@icloud.com   
Saarland University Medical Center Recruiting
Homburg, Saarland, Germany, 66421
Contact: Ulrich Laufs, Prof       ulrich@laufs.com   
Contact: Anja Zickwolf       Anja.Zickwolf@uks.eu   
Universitätsklinikum Jena Friedrich-Schiller-Universität Jena Recruiting
Jena, Thuringia, Germany, 07740
Contact: PC Schulze, Prof       Romy.Scholze@med.uni-jena.de   
Charité University Medicine Berlin Recruiting
Berlin, Germany, 13353
Contact: Wolfram Doehner, Prof.       wolfram.doehner@charite.de   
Contact: Nadja Scherbakov, Dr       nadja.scherbakov@charite.de   
Klinikum Lippe Recruiting
Detmold, Germany, 32756
Contact: Stephan Gielen, Prof    00495231725727    Stephan.Gielen@klinikum-lippe.de   
Contact: Melanie Kriete       Melanie.Kriete@klinikum-lippe.de   
Universitätsklinikum Halle Recruiting
Halle (Saale), Germany, 06120
Contact: Michael Nutsias, Prof    00493452795763524    michael.noutsias@uk-halle.de   
Medizinische Hochschule Hannover Klinik für Kardiologie und Angiologie Recruiting
Hamburg, Germany, 20095
Contact: Mahir Karakas, Dr       m.karakas@uke.de   
Contact: Beatrix Mattes       b.mattes@uke.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
University of Göttingen
Investigators
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Principal Investigator: Wolfram Doehner, Prof Charite University, Berlin, Germany

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Responsible Party: Doehner, W, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03074591     History of Changes
Other Study ID Numbers: Charite
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Doehner, W, Charite University, Berlin, Germany:
Iron deficiency
Heart failure

Additional relevant MeSH terms:
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Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics