IRONOUT-HF: Oral Iron Repletion effects On Oxygen UpTake in Heart Failure

Project: Research project

Project Details

Description

Brief Rationale
Therapeutic options to further improve functional capacity and symptoms in
HF beyond neurohormonal antagonism are limited. Studies have
demonstrated impaired oxidative capacity of skeletal muscle among HF
patients, which may contribute to symptoms of breathlessness and
persistent fatigue.
In addition to its role in erythropoiesis, iron (Fe) plays a critical role in
skeletal muscle’s oxygen (O2)-storage capacity (myoglobin) and systemic
aerobic energy production. As Fe deficiency is common in patients with
symptomatic HF, repletion of iron stores may improve submaximal exercise
capacity among these patients beyond the effects on erythropoiesis.
While intravenous Fe repletion in HF patients with mild Fe-deficiency (i.e.
Ferritin <100 or Ferritin 100-299 with transferrin saturation <20%) with or
without anemia global well-being and functional status, oral Fe repletion
has not been studied. Furthermore, the efficacy of oral Fe to replete iron
stores in a similar population and its impact on functional capacity,
measured objectively by peak VO2, remains unknown.

Primary Objective Multi-center, randomized, double-blind, placebo-controlled study for 16 weeks duration. To determine if oral iron polysaccharide is superior to oral placebo in improving the peak VO2as assessed by cardiopulmonary
exercise testing (CPET) of a broad population patients with HFrEF and Fe
deficiency at 16 weeks. Approximately 20 clinical centers in the United
States and Canada.
Secondary Objectives

To determine the impact of oral Fe repletion on:
a. Submaximal exercise capacity: O2 uptake kinetics and ventilatory
efficiency as measured by CPET and 6 minute walk distance
b. Plasma NT-proBNP
c. Health status: KCC Questionnaire (KCCQ)
StatusFinished
Effective start/end date1/26/1510/31/18

Funding

  • Duke University (177494/200464/029692//U10HL084904)
  • National Heart, Lung, and Blood Institute (177494/200464/029692//U10HL084904)

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