The purpose of the study is to evaluate whether the administration of iron to patients with heart failure and preserved ejection fraction results in an improvement of symptoms and functional class, in addition to evaluating whether oral iron is equivalent to intravenous iron to achieve this improvement.
Iron deficiency is one of the most prevalent co-morbid conditions in chronic heart failure. In the absence of any iron treatment, it is estimated that up to 50% of patients with heart failure have low levels of available iron. Treatment with intravenous iron improves exercise tolerance , quality of life , and reduces hospitalization in patients with chronic heart failure and reduced ejection fraction. However data on the effect of iron therapy in patients with heart failure with preserved ejection fraction are still lacking. The evidence related to oral iron therapy in HF is limited and no randomized trials compared oral iron vs no iron therapy in the absence of erythropoiesis-stimulating agents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
The group assigned to placebo will receive an infusion of normal saline solution plus oral lactose capsules identical to oral medication.
The group assigned to receive intravenous iron will receive intravenous ferric carboxymaltose ajusted by weight and Hb levels according to study protocol plus oral placebo
One group assigned to receive oral iron will receive two 100 mg oral capsule of ferroglycine sulfate plus intravenous placebo (normal saline solution)
Hospital Universitari Arnau de Vilanova
Lleida, Lleida, Spain
Hospital de Manises
Manises, Valencia, Spain
Six minute walking test distance
Change in meters traveled in six minute walking test from baseline to week 24. An increase in distance is related to an improvement in functional capacity.
Time frame: 24 weeks
Change in New York Heart Association (NYHA) functional classification
Change in New York Heart Association functional classification (I-IV) from baseline to week 24. A decrease is related to an improvement in functional capacity.
Time frame: 24 weeks
Quality of Life assesed by Kansas City Cardiomyopathy Questionnaire
Change in Minnesota Living with Heart Failure questionnaire (0-100) from baseline to week 24. Questionnaire is s a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Time frame: 24 weeks
Hospitalizations
Rate of any, HF-related or other cardiovascular hospitalizations.
Time frame: 24 weeks
Mortality
All causes and cardiovascular mortality
Time frame: 24 weeks
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One group assigned to receive oral iron will receive or two oral capsule containing 30 mg of pyrophosphate sucrosomial iron plus intravenous placebo (normal saline solution)