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A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency (CONFIRM-HF)

Primary Purpose

Iron Deficiency, Chronic Heart Failure

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ferinject (ferric carboxymaltose)
Placebo (saline)
Sponsored by
Vifor Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency

Eligibility Criteria

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

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:

  • 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

Sites / Locations

  • Clinical Military Hospital
  • State Educational Institution of Higer Professional Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ferinject (ferric carboxymaltose)

Placebo (saline)

Arm Description

Outcomes

Primary Outcome Measures

Change in six minute walk test from baseline to week 24

Secondary Outcome Measures

Full Information

First Posted
October 13, 2011
Last Updated
March 17, 2015
Sponsor
Vifor Pharma
Collaborators
ICON Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT01453608
Brief Title
A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Acronym
CONFIRM-HF
Official Title
A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vifor Pharma
Collaborators
ICON Clinical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Chronic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferinject (ferric carboxymaltose)
Arm Type
Experimental
Arm Title
Placebo (saline)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ferinject (ferric carboxymaltose)
Intervention Description
Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0
Intervention Type
Drug
Intervention Name(s)
Placebo (saline)
Intervention Description
Subjects will receive Placebo (saline) intravenously on Day 0
Primary Outcome Measure Information:
Title
Change in six minute walk test from baseline to week 24
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Ponikowski, MD
Organizational Affiliation
Cardiology Department - Centre for Heart Disease - Clinical Military Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Military Hospital
City
Wroclaw
ZIP/Postal Code
50-891
Country
Poland
Facility Name
State Educational Institution of Higer Professional Education
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
25176939
Citation
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.
Results Reference
derived
Links:
URL
http://eurheartj.oxfordjournals.org/content/early/2014/11/20/eurheartj.ehu385
Description
Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. Confirm HF

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

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