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

Conditions: Iron deficiency in patients with chronic heart failure
MedDRA version: 14.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 14.1Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-001695-19-PT

Lead Sponsor: Vifor (International) Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>2. To evaluate the effect of IV FCM compared to placebo on relevant biomarkers/laboratory parameters.<br><br>3. To evaluate the effect of IV FCM compared to placebo on <br>health related quality of life (QoL).<br><br>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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Patient global assessment (PGA) score at Weeks 6, 12, 24, 36 and 52.<br>2. Change in NYHA class at Weeks 6, 12, 24, 36 and 52.<br>3. Change in 6MWT distance from baseline to Weeks 6, 12, 36 and 52.<br>4. Change in fatigue score from baseline to Weeks 6, 12, 24, 36 and 52.<br>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).<br>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<br>

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