title: Rationale and design of a pilot randomized controlled trial to assess the role of intravenous ferric carboxymaltose in Asian patients with heart failure (PRACTICE-ASIA-HF).
abstract: OBJECTIVE
  Iron deficiency (ID) is highly prevalent in patients with heart failure (HF) worldwide regardless of haemoglobin levels. Results from therapeutic trials of intermittently dosed intravenous (i.v.) iron are promising in the ambulatory Caucasian population with HF with reduced left ventricular ejection fraction, although evidence is scarce in Asia. The Pilot Randomized Controlled Trial to Assess the Role of Intravenous Ferric Carboxymaltose in Asian Patients with Heart Failure aims to assess the effect of single-dose i.v. ferric carboxymaltose (FCM) in a multi-ethnic Asian population with HF and ID.
  
  
  RESULTS
  This is an open-label, randomized, placebo-controlled trial recruiting stabilized inpatients with decompensated HF (regardless of left ventricular ejection fraction), ID [defined as serum ferritin <300 ng/mL if transferrin saturation <20%] and haemoglobin ≤14 g/dL. Patients from two tertiary institutions were randomized in a 1:1 ratio to receive a single dose of either i.v. FCM (Ferinject®) 1000 mg or i.v. normal saline. The primary endpoint is the change in 6-min walk distance at Weeks 4 and 12, and secondary endpoints are changes at Weeks 4 and 12 in (i) quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and Visual Analogue Scale scores and (ii) New York Heart Association functional class.
  
  
  CONCLUSIONS
  Preliminary efficacy data on i.v. FCM therapy in Asian HF are expected from this pilot study to support larger-scale multicentre therapeutic i.v. FCM trials within Asia.
authors: National University Heart Centre Singapore National University Health System Singapore.
authors: Tee Joo
authors: TJ
authors: Yeo
authors: Tan Tock Seng Hospital Apex Heart Clinic Gleneagles Hospital Singapore.
authors: Poh Shuan Daniel
authors: PS
authors: Yeo
authors: Vifor Pharma Asia Pacific Singapore.
authors: Farid Abdul
authors: FA
authors: Hadi
authors: Vifor Pharma Asia Pacific Singapore.
authors: Timothy
authors: T
authors: Cushway
authors: National University Heart Centre Singapore National University Health System Singapore.
authors: Kim Yee
authors: KY
authors: Lee
authors: Saw Swee Hock School of Public Health National University of Singapore Singapore.
authors: Bee Choo
authors: BC
authors: Tai
authors: National University Heart Centre Singapore National University Health System Singapore.
authors: Carolyn S P
authors: CS
authors: Lam
keywords: Heart failure; Intravenous iron