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CompletedNCT01453608CONFIRM-HFUpdated Mar 18, 2015

A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

A Phase 4 interventional study of Ferinject (ferric carboxymaltose) and Placebo (saline) in Iron Deficiency and Chronic Heart Failure, sponsored by Vifor Pharma. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Vifor Pharma · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
304
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.

02

Conditions studied

  • Iron Deficiency
  • Chronic Heart Failure
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 304 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Vifor Pharma is the lead sponsor of 21 studies on the registry; none 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

  • Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
  • Reduced left ventricular ejection fraction
  • Capable of completing 6 minute walk test
  • At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion criteria

Exclusion Criteria:

  • Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation
  • Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
  • Chronic liver disease and/or elevated liver enzymes
  • Vitamin B12 and/or serum folate deficiency
  • Subject is not using adequate contraceptive precautions during the study
  • Body weight ≤ 35 kg
  • No other significant cardiac or general disorders that would compromise the ability to give informed consent and/or comply with study procedures
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
304 participants (actual)

Study arms

  • Experimental
    Ferinject (ferric carboxymaltose)

    Drug: Ferinject (ferric carboxymaltose)

  • Placebo comparator
    Placebo (saline)

    Drug: Placebo (saline)

Interventions

  • DrugFerinject (ferric carboxymaltose)

    Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0

  • DrugPlacebo (saline)

    Subjects will receive Placebo (saline) intravenously on Day 0

06

What researchers measure

Primary outcomes

  1. Change in six minute walk test from baseline to week 24

    Time frame: 24 weeks

07

Study locations

2 sites
  • Clinical Military Hospital
    Wroclaw, 50-891, Poland
  • State Educational Institution of Higer Professional Education
    Ryazan, 390039, Russian Federation
08

References and documents

Publications

  • Ponikowski P, van Veldhuisen DJ, Comin-Colet J, Ertl G, Komajda M, Mareev V, McDonagh T, Parkhomenko A, Tavazzi L, Levesque V, Mori C, Roubert B, Filippatos G, Ruschitzka F, Anker SD; CONFIRM-HF Investigators. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiencydagger. Eur Heart J. 2015 Mar 14;36(11):657-68. doi: 10.1093/eurheartj/ehu385. Epub 2014 Aug 31. PubMed 25176939 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01453608
Lead sponsor
Vifor Pharma
Collaborators
ICON Clinical Research
Responsible party
Sponsor
First posted
Oct 18, 2011
Start date
Oct 2011
Primary completion
Feb 2014
Completion
Jan 2015
Last update
Mar 18, 2015

Study contacts

Piotr Ponikowski, MD
principal investigator · Cardiology Department - Centre for Heart Disease - Clinical Military Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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