Iron deficiency in patients with chronic heart failure MedDRA version: 14.1 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849 MedDRA version: 14.1 Level: PT Classification code 10022970 Term: Iron deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
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-
Sponsors
Vifor (International) Inc.
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 exercise capacity 3. Reduced left ventricular ejection fraction 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 96
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 that requires treatment 5. Subject is not using adequate contraceptive precautions during the study 6. No other significant cardiac or general disorder that would compromise participation in the study. 7. Subjects with body weight <35 kg 8. Subject has previously been randomized in FER-CARS-05. 9. Cardio resynchronization therapy device implantation within 6 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the efficacy of intravenous ferric carboxymaltose compared to usual care on exercise capacity.;Secondary Objective: 1. To evaluate the efficacy of IV FCM compared to usual care on biomarkers for iron deficiency (ID), cardiac biomarkers, New York Heart Association (NYHA) functional class, patient global assessment (PGA), quality of life (QoL), renal function, cardiac function as assessed by echocardiography (ECHO) and iron requirements in iron-deficient chronic heart failure (CHF) subjects. 2. To evaluate the safety of intravenous ferric carboxymaltose over the treatment period. ;Primary end point(s): Change in peak VO2 (mL/kg/min) from baseline to Week 24;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in peak VO2 (mL/kg/min) from baseline to Week 12 2. Change in minute ventilation-carbon dioxide production slope from baseline to Weeks 12 and 24 3. Change in work rate achieved at peak exercise from baseline to Weeks 12 and 24. 4. Changes from baseline to Weeks 6, 12 and 24 in: - Key laboratory and iron parameters - Cardiac biomarkers (including BNP and NT-proBNP) - NYHA - PGA - QoL (Kansas City cardiomyopathy questionnaire (KCCQ) and European quality of life 5D questionnaire (EQ-5D)) 5. Change from baseline to Weeks 12 and 24 in ECHO measurements. 6. Cumulative iron requirements and number of iron administrations over the study period 7. Percentage of subjects meeting key safety endpoint defined as time to: - Death - (First) hospitalisation for worsening heart failure - Heart transplantation;Timepoint(s) of evaluation of this end point: 1. Week 12 2. Week 12 & Week 24 3. Week 12 & Week 24 4. Week 6, Week 12, & Week 24 5. Week 12 & Week 24 6. End of Study 7. End of Study | — |
Countries
Australia, Belgium, France, Germany, Italy, Netherlands, Poland, Russian Federation, Spain
Contacts
Public ContactMedical Information
Vifor (International) Inc.
Outcome results
None listed