Iron and Heart Trial
Research type
Research Study
Full title
Exploratory multicentre prospective double blinded randomised controlled pilot study of the effect of intravenous iron supplementation(Monofer)in iron deficient but not anaemic patients with Chronic Kidney Disease stages 3b or worse on functional status and cardiac structure and function.
IRAS ID
165121
Contact name
Sunil Bhandari
Contact email
Sponsor organisation
Hull and east Yorkshire Hospitals Trust
Eudract number
2014-004133-16
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The overall aim of this study is exploratory to provide pilot data to examine whether IV iron therapy in patients with CKD stages 3b-5 (non-dialysis) can improve symptoms, physical function, exercise capacity and cardiac function. The study will also determine whether there is any value in progressing to a large RCT. The proposed study will provide new data where there is a shortfall, and allow future “hypothesis generation” in this clinical area.Specifically, we propose to examine whether a strategy of IV parenteral iron therapy in patients with stages 3b-5 CKD who are iron deficient (Ferritin < 100 µg/L and TS%<20) but NOT anaemic (haemoglobin 110-150g/L) leads to improved functional capacity as measured by the 6MWT and physical capacity as assessed by qualitative questionnaires (KDQol and MLHF) and also stabilisation or improvement in cardiac function over a one month follow-up period, with reassessment at 3 months, compared to a strategy of continuing current therapy without additional iron therapy. A third arm consisting of a control group of patients with CKD and no anaemia or iron deficiency will allow for baseline comparisons, while a forth arm of normal patients will also serve as a baseline control.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1209
Date of REC Opinion
23 Jan 2015
REC opinion
Further Information Favourable Opinion