NCT01453608

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2011

Typical duration for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

October 13, 2011

Last Update Submit

March 17, 2015

Conditions

Iron DeficiencyChronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Change in six minute walk test from baseline to week 24

    24 weeks

Study Arms (2)

Ferinject (ferric carboxymaltose)

EXPERIMENTAL
Drug: Ferinject (ferric carboxymaltose)

Placebo (saline)

PLACEBO COMPARATOR
Drug: Placebo (saline)

Interventions

Ferinject (ferric carboxymaltose)DRUG

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

Ferinject (ferric carboxymaltose)
Placebo (saline)DRUG

Subjects will receive Placebo (saline) intravenously on Day 0

Placebo (saline)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Military Hospital

Wroclaw, 50-891, Poland

Location

State Educational Institution of Higer Professional Education

Ryazan, 390039, Russia

Location

Related Publications (1)

  • 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.

    PMID: 25176939DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferric carboxymaltoseSodium Chloride

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Piotr Ponikowski, MD

    Cardiology Department - Centre for Heart Disease - Clinical Military Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 18, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2014

Study Completion

January 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

PL(1)RU(1)