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

March 17, 2015 updated by: Vifor Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ferinject (ferric carboxymaltose)
Drug: Ferinject (ferric carboxymaltose)
Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0
Placebo Comparator: Placebo (saline)
Drug: Placebo (saline)
Subjects will receive Placebo (saline) intravenously on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in six minute walk test from baseline to week 24
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vifor Pharma

Collaborators

ICON Clinical Research

Investigators

  • Principal Investigator: Piotr Ponikowski, MD, Cardiology Department - Centre for Heart Disease - Clinical Military Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 18, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER-CARS-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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