Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Heart failure (HF) is a major global public health issue which also affects Asia. Data from
the National Registry of Disease in Singapore shows a 9.4% rise in HF admissions in public
hospitals from 2008 to 2009 (4140 to 4530). Anaemia (low blood Haemoglobin level) is a common
problem occurring 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.Novel approaches are required to address this
problem. Iron deficiency (ID) is a well-understood cause of anaemia. ID without overt anaemia
may be present in HF patients. A recent study by Jankowska et al published in 2010 of 546 HF
patients showed a 37% prevalence of ID, regardless of Haemoglobin level. This was associated
with worse outcomes including impaired exercise capacity. The presence of ID indicates a
higher likelihood of deteriorating and dying early. A landmark study published in the New
England Journal of Medicine (The Ferinject Assessment in Patients with Iron Deficiency and
Chronic Heart Failure (FAIR-HF) study) showed that HF patients who were treated with IV iron
in the form of Ferric Carboxymaltose (FCM) had better outcomes, including improved exercise
capacity, overall function, and quality of life.
There is a lack of contemporary data on ID in HF patients in Asia, including data on
treatment with this novel IV iron FCM.
Hypothesis We hypothesise that treating ID in HF patients in Asia using FCM will improve
outcomes including exercise capacity, quality of life, overall functional status, and the
need to be hospitalised for complications arising from HF.
Phase:
Phase 4
Details
Lead Sponsor:
National University Hospital, Singapore
Collaborators:
National University Heart Centre, Singapore Tan Tock Seng Hospital