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TerminatedNCT01837082iCHFUpdated May 13, 2016

Iron in Congestive Heart Failure

A Phase 3 interventional study of ferric carboxymaltose and Placebo in Heart Failure, Iron Deficiency and Anemia, sponsored by University of Ulm. Terminated at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-13.

Sponsored by University of Ulm · Phase 3, Interventional, and Treatment

Why this study was terminated
Insufficient recruitment
Phase
Phase 3
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve left-ventricular ejection fraction in patients with heart failure and iron deficiency as determined by cardiac magnetic resonance imaging.

02

Conditions studied

  • Heart Failure
  • Iron Deficiency
  • Anemia

Keywords

  • Heart Failure
  • Iron Deficiency
  • Anemia
  • Ferric Carboxymaltose
03

In context

Heart Failure

5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 18 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Congestive heart failure
  • At least 18 years of age
  • Iron deficiency
  • Dyspnea class II or III according to New York Heart Association
  • Left-ventricular ejection fraction ≤ 45%

Exclusion criteria

Exclusion Criteria:

  • Known sensitivity to any of the products to be administered during dosing
  • Immediate need of transfusion
  • Patients presenting with an active infection
  • Thalassaemia
  • Other forms of microcytic anemia not caused by iron deficiency
  • History of acquired iron overload
  • Need for revascularization, ST-segment elevation myocardial infarction or Non-ST-segment elevation myocardial infarction during the past 3 months (at time of randomization)
  • Women who are pregnant or of childbearing age and not using medically acceptable effective contraception
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Iron

    ferric carboxymaltose

    Drug: ferric carboxymaltose

  • Placebo comparator
    Placebo

    Sodium chloride 0.9%

    Drug: Placebo

Interventions

  • Drugferric carboxymaltose

    Also known as: Ferinject

  • DrugPlacebo

    Also known as: Sodium chloride 0.9%

06

What researchers measure

Primary outcomes

  1. The primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging.

    Time frame: 12 weeks

07

Study locations

3 sites
  • University of Aachen
    Aachen, 52074, Germany
  • University Heart Center Hamburg
    Hamburg, 20251, Germany
  • University of Ulm
    Ulm, 89081, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01837082
Lead sponsor
University of Ulm
Collaborators
RWTH Aachen University, Universitätsklinikum Hamburg-Eppendorf
Responsible party
Dr. Mahir Karakas (Dr. med., University of Ulm) — Principal investigator
First posted
Apr 22, 2013
Start date
Apr 2013
Primary completion
Dec 2015
Completion
Dec 2015
Last update
May 13, 2016

Study contacts

Mahir Karakas, MD
principal investigator · University of Ulm

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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