Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure

Launched by NATIONAL UNIVERSITY HOSPITAL, SINGAPORE · Aug 11, 2013

Keywords

ClinConnect Summary

Heart failure (HF) is a major global public health issue which also affects Asia. Singapore National Registry of Disease data shows a 9.4% rise in public hospital HF admissions from 2008 to 2009 (4140 to 4530). Anaemia (low blood Haemoglobin level) is a common co-morbidity in HF, ranging from 14% to 56% in outpatient registries and clinical trials. Anaemia exacerbates the basic symptoms of HF of dyspnea and exercise intolerance, thereby reducing quality of life (QoL). However, recent approaches aimed at improving and normalizing Haemoglobin have been unsuccessful (STAMINA-HeFT, RED-HF).Nove...

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Eligibility criteria

• Inclusion Criteria:
• • Patients hospitalized for HF (regardless of LVEF)
• • Capable of completing the 6MWT
• • Screening TSAT \<20%, Serum Ferritin \<300 ng/mL and Hb≤14 g/dL
• • At least 21 years of age
• • Written informed consent.
• Exclusion Criteria:
• • Acute coronary syndrome
• • Acute valvular heart dysfunction
• • Known sensitivity to FCM
• • IV iron therapy and/or blood transfusion in the 4 weeks prior to randomisation
• • Body weight ≤35 kg
• • Active bacterial infection
• • Haemochromatosis or other iron storage disorder
• • Serious medical condition, emergency condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from participating or potentially completing the study
• • Planned participation in any other interventional study or having received trial medication in the context of a clinical trial within the last 4 weeks prior to participating in this trial.