NCT02188784

Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Adrian Hernandez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if oral iron (Fe) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 (oxygen uptake) by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks. Hypothesis: In a broad population of HFrEF patients with Fe deficiency, compared to oral placebo, therapy with oral Fe polysaccharide will be associated with improvement in functional capacity at 16 weeks as assessed by CPET.

Detailed description

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.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	Polysaccharide Iron Complex 150 mg	Oral Iron
DRUG	Placebo (for Polysaccharide Iron Complex)	Sugar capsule designed to mimic Polysaccharide Iron Complex.

Timeline

• Start date: 2014-09-03
• Primary completion: 2016-04-06
• Completion: 2016-04-06
• First posted: 2014-07-14
• Last updated: 2017-07-11
• Results posted: 2017-05-15

Locations

17 sites across 1 country: United States