Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure
Phase 3
Completed
- Conditions
- Chronic Heart FailureIron Deficiency
- Interventions
- Drug: Ferinject (ferric carboxymaltose)Other: Standard of Care
- Registration Number
- NCT01394562
- Lead Sponsor
- Vifor Pharma
- Brief Summary
The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
Inclusion Criteria
- Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
- Reduced exercise capacity
- Reduced left ventricular ejection fraction
- 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
- No other significant cardiac or general disorder that would compromise participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ferinject (ferric carboxymaltose) Ferinject (ferric carboxymaltose) - Standard of Care Standard of Care Standard of care. IV iron is not permitted
- Primary Outcome Measures
Name Time Method Change in Peak VO2 (mL/kg/min) from baseline to Week 24 Week 24
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie ferric carboxymaltose's improvement of exercise capacity in chronic heart failure patients with iron deficiency?
How does IV ferric carboxymaltose compare to oral iron supplements in managing iron deficiency in chronic heart failure patients?
Which biomarkers are associated with response to ferric carboxymaltose treatment in chronic heart failure patients with iron deficiency?
What are the potential adverse events of ferric carboxymaltose therapy in chronic heart failure patients and how can they be managed?
Are there any combination therapies involving ferric carboxymaltose that enhance outcomes in chronic heart failure patients with iron deficiency?
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands
University Medical Center Groningen🇳🇱Groningen, Netherlands