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

AimsIron 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.Methods and resultsThis 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.ConclusionsPreliminary 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.

Single‐dose intravenous iron in Southeast Asian heart failure patients: A pilot randomized placebo‐controlled study (PRACTICE‐ASIA‐HF)

“…The study design has been published. 15 The study protocol was approved by the local ethics institutional regulatory board and conducted in accordance with the principles of the World Medical Association Declaration of Helsinki on ethics in medical research and International Conference on Harmonization guidelines for Good Clinical Practice. Written informed consent was obtained from all participants.…”

Iron deficiency in patients with heart failure with preserved ejection fraction and its association with reduced exercise capacity, muscle strength and quality of life

“…Iron plays a key role in oxygen uptake, transport, and storage, as well as oxidative metabolism in the skeletal muscle; it is also involved in erythropoiesis.13,14 However, erythropoiesis remains undisturbed until late in the course of iron depletion.15,16 Indeed, it has been reported that iron deficiency (ID) with or without anemia impairs the aerobic performance and leads to fatigue and exercise intolerance. [17][18][19] It is also known that the intravenous repletion -as opposed to oral administration -20 of iron in patients with HFrEF improves functional capacity, symptoms and QoL and may be associated with reduced hospitalization rates for worsening in HF. 10,21 ID is an extremely common nutritional disorder that affects up to 2 billion people worldwide,15 and it has recently been reported as a frequent co-morbidity in stable HF patients 22-24.…”

Co‐morbidities in heart failure beginning to sprout—and no end in sight?

“…Very recent data have shown that patients with HF who are iron deficient are unlikely to benefit from oral iron administration, because data from the IRONOUT HF study have shown that oral iron is poorly absorbed in the duodenum and its prescription not associated with an increase in the patients' peak VO 2 value . However, further studies are well under way to strengthen our views and positive evaluations of treating iron deficiency in patients with HF, for example, the PRACTICE‐ASIA‐HF study, the FAIR‐HF 2 trial, or the FAIR‐HFpEF trial …”