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Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality (FAIR-HF2)

Primary Purpose

Systolic Heart Failure, Iron Deficiency

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Iron
Saline
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systolic Heart Failure focused on measuring intravenous iron, systolic heart failure, iron deficiency, morbidity, mortality

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with chronic HFrEF (CHF) of at least 3 months duration and a history of documented LVEF<45%.
  2. Confirmed presence of ID (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT < 20 %)
  3. Serum haemoglobin of 9.5 - 14.0 g/dL
  4. At time of screening considered re-stabilised and planned for discharge within next 24 h (NYHA 2 or 3), or stable ambulatory with a HF hospitalisation in the past 12 months (NYHA 2-4), or stable ambulatory with BNP > 100 pg/mL or NT-proBNP > 300 pg/mL or MR-proANP > 120 pmol/L (NYHA 2-4)
  5. Written informed consent

Exclusion Criteria:

  1. Hypersensitivity to the active substance, to FCM or any of its excipients
  2. Known serious hypersensitivity to other parenteral iron products
  3. Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia
  4. Evidence of iron overload or disturbances in the utilisation of iron
  5. History of severe asthma with known FEV1 <50%
  6. Acute bacterial infection
  7. Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs to be corrected first)
  8. Use of renal replacement therapy
  9. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomisation.
  10. More than 500 meters in the initial 6-minutes walking-test

Sites / Locations

  • SLK-Kliniken Heilbronn GmbH Klinikum am PlattenwaldRecruiting
  • Kerckhoff Klinik Bad NauheimRecruiting
  • Studienzentrum Rankestrasse
  • Universitätsmedizin Berlin Campus Benjamin FranklinRecruiting
  • Charité Berlin (Campus Virchow-Klinikum)Recruiting
  • Stiftung Bremer Herzen Bremer Institut für Herz- und Kreislauf- ForschungRecruiting
  • Herzzentrum Dresden, Universitätsklinik
  • Uniklinik Greifswald, Klinik und Poliklinik für Innere Medizin BRecruiting
  • Universitätsmedizin GöttingenRecruiting
  • Universitätsklinikum Halle (Saale)
  • Universitärsklinikum Hamburg-EppendorfRecruiting
  • Cardiologicum HamburgRecruiting
  • Universitätsklinikum HeidelbergRecruiting
  • Universitätsklinikum des SaarlandesRecruiting
  • Universitätsklinikum Jena, KardiologieRecruiting
  • Universitätsklinikum Schleswig-Holstein Campus KielRecruiting
  • Universitätsklinikum Schleswig-Holstein Campus LübeckRecruiting
  • Universitätsklinikum MagdeburgRecruiting
  • Universitätsmedizin der Johannes Gutenberg-Universität MainzRecruiting
  • Universitätsmedizin MannheimRecruiting
  • Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie
  • Praxis Dr. Schön Mühldorf
  • LMU München Medizinische Klinik und Poliklinik 1Recruiting
  • Klinikum rechts der Isar I. Medizinische Klinik und Poliklinik
  • Gemeinschaftspraxis Hagenmiller/ JeserichRecruiting
  • Universitätsklinik Medizinische Klinik 8 - Kardiologie Paracelsus Medizinische Privatuniversität Klinikum Nürnberg, Campus Süd
  • KardioPrax RemscheidRecruiting
  • Kardiologische Praxis Dr. Jens PlackeRecruiting
  • Studienzentrum Herzklinik Ulm GbR
  • Universitätsklinikum UlmRecruiting
  • Szent Imre Kórház
  • Semmelweis EgyetemRecruiting
  • Szent János kórház és Észak-budai Egyesített kórházak
  • Honvéd KórházRecruiting
  • Pécsi OrvostudományiRecruiting
  • Almási Balogh Pál KórházRecruiting
  • IRCCS San Raffaele Pisana (06-01)Recruiting
  • Cermed Hernik (05-07)
  • Oddział Kardiologii Uniwersyteckiego (05-06)
  • Klinika Niewydolności Serca I Transplantologii (05-04)Recruiting
  • Wroclaw Medical University (05-01)Recruiting
  • KLIMED Marek Klimkiewicz Lomza (05-05)
  • Hospital de la LuzRecruiting
  • Santa Maria University HospitalRecruiting
  • Clinical Hospital Center Zemun
  • Clinical Center of Serbia, Department of Cardiology
  • Clinical Hospital Center Zvezdara
  • Institute of Cardiovascular Diseases "Dedinje"
  • General Hospital "Sveti Luka"
  • Institute for Cardiovascular Diseases of Vojvodina
  • University Medical Centre Ljubljana (07-03)Recruiting
  • General Hospital Murska Sobota Division of Cardiology (07-01)Recruiting
  • Hospital Topolšica (07-03)Recruiting
  • Hospital del Mar (04-01)
  • Hospital Universitario Clinico San Carlos Madrid (04-04)
  • Hospital Universitarion Virgen de la Victoria (04-03)
  • Hospital Clinico Universitario Valencia (04-02)
  • Hospital la Fe de Valencia (04-05)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum group (FCM)

Placebo group (NaCL)

Arm Description

I.v. iron administration in the form of FCM will be carried out according to SmPC. I.v. iron 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 the approved dosing rules, followed by administration of 500 mg FCM at every 4 months, except when haemoglobin is > 16.0 g/dL or ferritin is > 800 µg/L .In the verum group, all patients will receive a saline administration, when no iron is indicated at the time of the visit and according to the values listed above.

Administration of i.v. NaCl at a volume according to the dosing rules for FCM, i.e. as described for the verum group.

Outcomes

Primary Outcome Measures

Combined rate of recurrent hospitalisations for heart failure (HF) and of cardiovascular death (number of events)
Combined rate of recurrent hospitalisations for heart failure and of cardiovascular death during follow-up.

Secondary Outcome Measures

Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death (number of events)
Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death during follow-up
Combined rate of recurrent hospitalisations for any reason and of cardiovascular death (number of events)
Combined rate of recurrent hospitalisations for any reason and of cardiovascular death during follow-up
Rate of recurrent cardiovascular hospitalisations (number of events)
Rate of recurrent cardiovascular hospitalisations during follow-up
Rate of recurrent HF hospitalisations (number of events)
Rate of recurrent HF hospitalisations during follow-up
Rate of recurrent hospitalisations of any kind (number of events)
Rate of recurrent hospitalisations of any kind during follow-up
All-cause mortality (number of events)
All-cause mortality during follow-up
cardiovascular mortality (number of events)
cardiovascular mortality during follow-up
Changes in NYHA (New York Heart Association) functional class (scale)
Changes in NYHA functional class during follow-up
Changes in 6-minute walk-test (nomogram)
Changes in 6-minute walk-test during follow-up
Changes in EQ-5D (questionnaire)
Changes EQ-5D during follow-up
Changes in Patient Global Assessment (PGA) of wellbeing (questionnaire)
Changes in PGA of wellbeing during follow-up
Changes in renal parameters (laboratory parameters)
Changes in renal from baseline to end of follow-up
Changes in cardiovascular parameters (laboratory parameters)
Changes in cardiovascular parameters from baseline to end of follow-up
Changes in inflammatory parameters (laboratory parameters)
Changes in inflammatory parameters from baseline to end of follow-up
Changes in metabolic parameters (laboratory parameters)
Changes in metabolic parameters from baseline to end of follow-up

Full Information

First Posted
September 15, 2016
Last Updated
December 28, 2022
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03036462
Brief Title
Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality
Acronym
FAIR-HF2
Official Title
Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality - FAIR-HF2
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron deficiency and heart failure.
Detailed Description
The clinical trial is designed as an international, prospective, multi-centre, double-blind, parallel group, randomised, controlled, interventional trial to investigate whether a long-term therapy with i.v. iron (ferric carboxymaltosis) compared to placebo can reduce the rate of recurrent heart failure hospitalisations and cardiovascular (CV) death in patients with heart failure with reduced ejection fraction (HFrEF). I.v. iron administration in the form of ferric carboxymaltosis (FCM) will be carried out according to the Summary of Product Characteristics (SmPC). 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 FCM at every 4 months, except when haemoglobin is > 16.0 g/dL or ferritin is > 800 µg/L. In the verum group, all patients will receive a saline administration, when no iron is indicated at the time of the visit and according to the values listed above. Patients originally assigned to the placebo group will receive a saline administration at all visits. In the control group i.v. NaCl at a volume according to the dosing rules for FCM at all visits will be administered in a double-blind manner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic Heart Failure, Iron Deficiency
Keywords
intravenous iron, systolic heart failure, iron deficiency, morbidity, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum group (FCM)
Arm Type
Experimental
Arm Description
I.v. iron administration in the form of FCM will be carried out according to SmPC. I.v. iron 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 the approved dosing rules, followed by administration of 500 mg FCM at every 4 months, except when haemoglobin is > 16.0 g/dL or ferritin is > 800 µg/L .In the verum group, all patients will receive a saline administration, when no iron is indicated at the time of the visit and according to the values listed above.
Arm Title
Placebo group (NaCL)
Arm Type
Placebo Comparator
Arm Description
Administration of i.v. NaCl at a volume according to the dosing rules for FCM, i.e. as described for the verum group.
Intervention Type
Drug
Intervention Name(s)
Iron
Intervention Description
i.v. iron administration
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
salin
Intervention Description
i.v. NaCl administration
Primary Outcome Measure Information:
Title
Combined rate of recurrent hospitalisations for heart failure (HF) and of cardiovascular death (number of events)
Description
Combined rate of recurrent hospitalisations for heart failure and of cardiovascular death during follow-up.
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Secondary Outcome Measure Information:
Title
Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death (number of events)
Description
Combined rate of recurrent cardiovascular hospitalisations and of cardiovascular death during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Combined rate of recurrent hospitalisations for any reason and of cardiovascular death (number of events)
Description
Combined rate of recurrent hospitalisations for any reason and of cardiovascular death during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Rate of recurrent cardiovascular hospitalisations (number of events)
Description
Rate of recurrent cardiovascular hospitalisations during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Rate of recurrent HF hospitalisations (number of events)
Description
Rate of recurrent HF hospitalisations during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Rate of recurrent hospitalisations of any kind (number of events)
Description
Rate of recurrent hospitalisations of any kind during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
All-cause mortality (number of events)
Description
All-cause mortality during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
cardiovascular mortality (number of events)
Description
cardiovascular mortality during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Changes in NYHA (New York Heart Association) functional class (scale)
Description
Changes in NYHA functional class during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Changes in 6-minute walk-test (nomogram)
Description
Changes in 6-minute walk-test during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Changes in EQ-5D (questionnaire)
Description
Changes EQ-5D during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Changes in Patient Global Assessment (PGA) of wellbeing (questionnaire)
Description
Changes in PGA of wellbeing during follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Changes in renal parameters (laboratory parameters)
Description
Changes in renal from baseline to end of follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Changes in cardiovascular parameters (laboratory parameters)
Description
Changes in cardiovascular parameters from baseline to end of follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Changes in inflammatory parameters (laboratory parameters)
Description
Changes in inflammatory parameters from baseline to end of follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)
Title
Changes in metabolic parameters (laboratory parameters)
Description
Changes in metabolic parameters from baseline to end of follow-up
Time Frame
for a minimum average follow-up of >2 years (We aim for a minimum follow-up of 6 months for all patients)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with chronic HFrEF (CHF) of at least 3 months duration and a history of documented LVEF<45%. Confirmed presence of ID (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT < 20 %) Serum haemoglobin of 9.5 - 14.0 g/dL At time of screening considered re-stabilised and planned for discharge within next 24 h (NYHA 2 or 3), or stable ambulatory with a HF hospitalisation in the past 12 months (NYHA 2-4), or stable ambulatory with BNP > 100 pg/mL or NT-proBNP > 300 pg/mL or MR-proANP > 120 pmol/L (NYHA 2-4) Written informed consent Exclusion Criteria: Hypersensitivity to the active substance, to FCM or any of its excipients Known serious hypersensitivity to other parenteral iron products Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia Evidence of iron overload or disturbances in the utilisation of iron History of severe asthma with known FEV1 <50% Acute bacterial infection Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs to be corrected first) Use of renal replacement therapy Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomisation. More than 500 meters in the initial 6-minutes walking-test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahir Karakas, MD
Phone
0049 407410
Ext
57975
Email
m.karakas@uke.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Anker, MD
Email
s.anker@cachexia.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahir Karaks, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
City
Bad Friedrichshall
ZIP/Postal Code
74177
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas J Dengler, Dr. med.
Email
Thomas.Dengler@slk-kliniken.de
First Name & Middle Initial & Last Name & Degree
Cornelia Neatu, Dr. med.
Facility Name
Kerckhoff Klinik Bad Nauheim
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian W Hamm, MD
Facility Name
Studienzentrum Rankestrasse
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsmedizin Berlin Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M Leistner, MD
Facility Name
Charité Berlin (Campus Virchow-Klinikum)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Edelmann, MD
Facility Name
Stiftung Bremer Herzen Bremer Institut für Herz- und Kreislauf- Forschung
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harm Wienbergen, MD
Facility Name
Herzzentrum Dresden, Universitätsklinik
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Uniklinik Greifswald, Klinik und Poliklinik für Innere Medizin B
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Beug, MD
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan von Haehling, MD
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitärsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahir Karakas, MD
Facility Name
Cardiologicum Hamburg
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Paitazoglou, Dr. med.
Email
C.Paitazoglou@cardiologicum.net
First Name & Middle Initial & Last Name & Degree
Annette Schmidt
Email
A.Schmidt@cardiologicum.net
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lutz Frankenstein, MD
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Kindermann, MD
Facility Name
Universitätsklinikum Jena, Kardiologie
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarek Bekfani, Dr. med.
Email
Tarek.Bekfani@med.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Paul Christian Schulze, Prof
Email
'Christian.Schulze@med.uni-jena.de'
First Name & Middle Initial & Last Name & Degree
Tarek Bekfani, Dr.med
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Luedde, MD
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Graf, MD
First Name & Middle Initial & Last Name & Degree
Tobias Graf, MD
Facility Name
Universitätsklinikum Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Schmeißer, MD
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tommaso Gori, MD
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dösch, MD
Facility Name
Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Individual Site Status
Terminated
Facility Name
Praxis Dr. Schön Mühldorf
City
Mühldorf
ZIP/Postal Code
84453
Country
Germany
Individual Site Status
Terminated
Facility Name
LMU München Medizinische Klinik und Poliklinik 1
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kääb, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Stefan Kääb, Prof. Dr.
Facility Name
Klinikum rechts der Isar I. Medizinische Klinik und Poliklinik
City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Gemeinschaftspraxis Hagenmiller/ Jeserich
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Jeserich, MD
Facility Name
Universitätsklinik Medizinische Klinik 8 - Kardiologie Paracelsus Medizinische Privatuniversität Klinikum Nürnberg, Campus Süd
City
Nürnberg
ZIP/Postal Code
90471
Country
Germany
Individual Site Status
Terminated
Facility Name
KardioPrax Remscheid
City
Remscheid
ZIP/Postal Code
42853
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Detlev Moll, Dr.
First Name & Middle Initial & Last Name & Degree
Detlev Moll, Dr.
Facility Name
Kardiologische Praxis Dr. Jens Placke
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Placke, Dr. med.
Email
placke@telemed.de
First Name & Middle Initial & Last Name & Degree
Stephan Drawert, Dr. med.
Email
stephan.drawert@kliniksued-rostock.de
Facility Name
Studienzentrum Herzklinik Ulm GbR
City
Ulm
ZIP/Postal Code
89077
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jochen Woehrle, MD
Facility Name
Szent Imre Kórház
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Individual Site Status
Terminated
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bela Merkely, MD
Facility Name
Szent János kórház és Észak-budai Egyesített kórházak
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Individual Site Status
Terminated
Facility Name
Honvéd Kórház
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Róbert G Kiss, MD
Facility Name
Pécsi Orvostudományi
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kálmán Tóth, MD
Facility Name
Almási Balogh Pál Kórház
City
Ózd
ZIP/Postal Code
3600
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bélteczki János, Dr.
Facility Name
IRCCS San Raffaele Pisana (06-01)
City
Rome
ZIP/Postal Code
00163
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Volterrani, MD
First Name & Middle Initial & Last Name & Degree
Maurizio Volterrani, MD
Facility Name
Cermed Hernik (05-07)
City
Białystok
ZIP/Postal Code
15-270
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Oddział Kardiologii Uniwersyteckiego (05-06)
City
Opole
ZIP/Postal Code
45-401
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Gierlotka, Prof.
First Name & Middle Initial & Last Name & Degree
Marek Gierlotka, Prof
Facility Name
Klinika Niewydolności Serca I Transplantologii (05-04)
City
Warsaw
ZIP/Postal Code
04-743
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Przemyslaw Leszek, Prof
Email
przemyslaw.leszek@ikard.pl
First Name & Middle Initial & Last Name & Degree
Przemyslaw Leszek, Prof.
Facility Name
Wroclaw Medical University (05-01)
City
Warschau
ZIP/Postal Code
50-981
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Jankowska, Prof.
Email
ewa.jankowska@umed.wroc.pl
First Name & Middle Initial & Last Name & Degree
Ewa Jankowska, Prof.
Facility Name
KLIMED Marek Klimkiewicz Lomza (05-05)
City
Łomża
ZIP/Postal Code
18-404
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Hospital de la Luz
City
Lisbon
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Moraes Sarmento, MD
Facility Name
Santa Maria University Hospital
City
Lisbon
ZIP/Postal Code
1649-028
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dulce Brito, MD
First Name & Middle Initial & Last Name & Degree
Fausto Pinto, MD
Facility Name
Clinical Hospital Center Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandar Nešković, Prof.
First Name & Middle Initial & Last Name & Degree
Aleksandar Nešković, Prof.
Facility Name
Clinical Center of Serbia, Department of Cardiology
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milika Asanin, Dr.
Email
masanin2013@gmail.com
First Name & Middle Initial & Last Name & Degree
Milika Asanin
Facility Name
Clinical Hospital Center Zvezdara
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goran Lončar
First Name & Middle Initial & Last Name & Degree
Goran Lončar
Facility Name
Institute of Cardiovascular Diseases "Dedinje"
City
Belgrad
ZIP/Postal Code
11040
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petar Otašević
First Name & Middle Initial & Last Name & Degree
Petar Otašević
Facility Name
General Hospital "Sveti Luka"
City
Smederevo
ZIP/Postal Code
11300
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Predrag Petrović
First Name & Middle Initial & Last Name & Degree
Predrag Petrović
Facility Name
Institute for Cardiovascular Diseases of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nada Čemerlić Ađić, Prof.
First Name & Middle Initial & Last Name & Degree
Nada Čemerlić Ađić, Prof.
Facility Name
University Medical Centre Ljubljana (07-03)
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bojan Vrtovec, Prof.
First Name & Middle Initial & Last Name & Degree
Bojan Vrtovec, Prof.
Facility Name
General Hospital Murska Sobota Division of Cardiology (07-01)
City
Murska Sobota
ZIP/Postal Code
9000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitja Lainscak, Prof
Email
mitja.lainscak@guest.arnes.si
First Name & Middle Initial & Last Name & Degree
Mitja Lainscak, Prof
Facility Name
Hospital Topolšica (07-03)
City
Topolšica
ZIP/Postal Code
SI-3326
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucija Gaberšček Parežnik, Dr
Email
Lucija.Gabrscek@b-topolsica.si
First Name & Middle Initial & Last Name & Degree
Lucija Gaberš Parežnik, Dr
Facility Name
Hospital del Mar (04-01)
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Terminated
Facility Name
Hospital Universitario Clinico San Carlos Madrid (04-04)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon Bover, MD
Facility Name
Hospital Universitarion Virgen de la Victoria (04-03)
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose M Garcia Pinilla, MD
Facility Name
Hospital Clinico Universitario Valencia (04-02)
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Nuñez Villota, MD
Facility Name
Hospital la Fe de Valencia (04-05)
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Almenar Bonet, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

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