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

NCT ID: NCT01453608

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-01-31

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.

Conditions

Iron Deficiency; Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ferinject (ferric carboxymaltose)

Group Type: EXPERIMENTAL

Ferinject (ferric carboxymaltose)

Intervention Type: DRUG

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

Placebo (saline)

Group Type: PLACEBO_COMPARATOR

Placebo (saline)

Intervention Type: DRUG

Subjects will receive Placebo (saline) intravenously on Day 0

Interventions

Ferinject (ferric carboxymaltose)

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

Intervention Type: DRUG

Placebo (saline)

Subjects will receive Placebo (saline) intravenously on Day 0

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

Vifor Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Ponikowski, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Department - Centre for Heart Disease - Clinical Military Hospital

Locations

Clinical Military Hospital

Wroclaw, , Poland

State Educational Institution of Higer Professional Education

Ryazan, , Russia

Countries

Poland; Russia

References

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.

Reference Type: DERIVED

PMID: 25176939 (View on PubMed)

Other Identifiers

FER-CARS-05

Identifier Type: -

Identifier Source: org_study_id