A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency (CONFIRM-HF)
This study is currently recruiting participants.
Verified December 2012 by Vifor Inc.
Sponsor:
Vifor Inc.
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01453608
First received: October 13, 2011
Last updated: December 19, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Iron Deficiency Chronic Heart Failure |
Drug: Ferinject (ferric carboxymaltose) Drug: Placebo (saline) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Vifor Inc.:
Primary Outcome Measures:
- Change in six minute walk test from baseline to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453608
Contacts
| Contact: Nic Waddingham | +44 1276 853600 | nicola.waddingham@viforpharma.com |
Locations
| Poland | |
| Clinical Military Hospital | Recruiting |
| Wroclaw, Poland, 50-891 | |
| Principal Investigator: Piotr Ponikowski, MD | |
| Russian Federation | |
| State Educational Institution of Higer Professional Education | Recruiting |
| Ryazan, Russian Federation, 390039 | |
| Principal Investigator: Alexey Nizov, MD | |
Sponsors and Collaborators
Vifor Inc.
ICON Clinical Research
Investigators
| Principal Investigator: | Piotr Ponikowski, MD | Cardiology Department - Centre for Heart Disease - Clinical Military Hospital |
More Information
No publications provided
| Responsible Party: | Vifor Inc. |
| ClinicalTrials.gov Identifier: | NCT01453608 History of Changes |
| Other Study ID Numbers: | FER-CARS-05 |
| Study First Received: | October 13, 2011 |
| Last Updated: | December 19, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Austria: Ethikkommission France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee Germany: Federal Institute for Drugs and Medical Devices Germany: Ethics Commission Ireland: Ministry of Health Ireland: Medical Ethics Research Committee Italy: Ethics Committee Italy: Ministry of Health Poland: Ethics Committee Poland: Ministry of Health Portugal: National Pharmacy and Medicines Institute Portugal: Ethics Committee for Clinical Research Russia: Ministry of Health of the Russian Federation Russia: Ethics Committee Spain: Ethics Committee Spain: Ministry of Health Sweden: Medical Products Agency Sweden: Institutional Review Board United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Heart Failure Anemia, Iron-Deficiency Heart Diseases Cardiovascular Diseases Anemia, Hypochromic Anemia Hematologic Diseases |
Iron Metabolism Disorders Metabolic Diseases Ferric Compounds Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013