A study to compare the use of ferric carboxymaltose with placebo in patients with chronic heart failure and iron deficiency

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 - CONFIRM-HF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001695-19-AT

Enrollment

300

Registered

2011-09-28

Start date

2011-11-09

Completion date

Unknown

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency in patients with chronic heart failure MedDRA version: 14.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.0 Level: PT Classification code 10022970 Term: Iron deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Ferinject Pharmaceutical Form: Injection INN or Proposed INN: ferric carboxymaltose Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Ph

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF 2. Reduced left ventricular ejection fraction 3. Capable of completing 6 minute walk test (6MWT) 4. At least 18 years of age and with written informed consent prior to any study specific procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180

Exclusion criteria

Exclusion criteria: 1. Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation. 2. Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months 3.Chronic liver disease and/or elevated liver enzymes 4. Vitamin B12 and/or serum folate deficiency 5. Subject is not using adequate contraceptive precautions during the study 6. Body weight =35 kg 6. No other significant cardiac or general disorders that would comprise the ability to give informed consent and/or comply with study procedures

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To determine, relative to placebo, the effect of iron repletion therapy using intrravenous (IV) FCM on exercise capacity assessed by 6-minute walk test (6MWT) at 24 weeks after initiation of therapy in subjects with CHF and ID;Secondary Objective: 1. To evaluate the effect of IV FCM compared to placebo on New York Heart Association (NYHA) functional class. 2. To evaluate the effect of IV FCM compared to placebo on relevant biomarkers/laboratory parameters. 3. To evaluate the effect of IV FCM compared to placebo on health related quality of life (QoL). 4. To evaluate the tolerability and safety of IV FCM compared to placebo.;Primary end point(s): Change in 6 minute walk test (6MWT) from baseline to Week 24 visit after start of investigational drug;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Main Objective: 1. To determine, relative to placebo, the effect of iron repletion therapy using intrravenous (IV) FCM on exercise capacity assessed by 6-minute walk test (6MWT) at 24 weeks after initiation of therapy in subjects with CHF and ID;Secondary Objective: 1. To evaluate the effect of IV FCM compared to placebo on New York Heart Association (NYHA) functional class. 2. To evaluate the effect of IV FCM compared to placebo on relevant biomarkers/laboratory parameters. 3. To evaluate the effect of IV FCM compared to placebo on health related quality of life (QoL). 4. To evaluate the tolerability and safety of IV FCM compared to placebo.;Primary end point(s): Change in 6 minute walk test (6MWT) from baseline to Week 24 visit after start of investigational drug;Timepoint(s) of evaluation of this end point: Week 24

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Secondary

Measure	Time frame
Secondary end point(s): 1. Patient global assessment (PGA) score at Weeks 6, 12, 24, 36 and 52. 2. Change in NYHA class at Weeks 6, 12, 24, 36 and 52. 3. Change in 6MWT distance from baseline to Weeks 6, 12, 36 and 52. 4. Change in fatigue score from baseline to Weeks 6, 12, 24, 36 and 52. 5. Change in Kansas City cardiomyopathy questionnaire (KCCQ) from baseline to Weeks 6, 12, 24, 36 and 52 (overall summary score and symptom frequency score). 6. Change in European quality of life 5D (EQ-5D) questionnaire total score from baseline to Weeks 6, 12, 24, 36 and 52.;Timepoint(s) of evaluation of this end point: Week 6, 12, 24, 36, and 52	—

Measure

Time frame

Secondary end point(s): 1. Patient global assessment (PGA) score at Weeks 6, 12, 24, 36 and 52. 2. Change in NYHA class at Weeks 6, 12, 24, 36 and 52. 3. Change in 6MWT distance from baseline to Weeks 6, 12, 36 and 52. 4. Change in fatigue score from baseline to Weeks 6, 12, 24, 36 and 52. 5. Change in Kansas City cardiomyopathy questionnaire (KCCQ) from baseline to Weeks 6, 12, 24, 36 and 52 (overall summary score and symptom frequency score). 6. Change in European quality of life 5D (EQ-5D) questionnaire total score from baseline to Weeks 6, 12, 24, 36 and 52.;Timepoint(s) of evaluation of this end point: Week 6, 12, 24, 36, and 52

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Countries

Austria, France, Germany, Ireland, Italy, Poland, Portugal, Russian Federation, Spain, Sweden, Ukraine, United Kingdom

Contacts

Public ContactMedical Information

Vifor (International) Inc.

medinfo@viforpharma.com4158851 8222

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026