Rationale and design of a prospective randomized study of the effect of ferric carboxymaltose therapy on quality of life and clinical picture of heart failure with preserved ejection fraction in patients with iron deficiency

Introduction. The prevalence of iron deficiency (ID) among patients with chronic heart failure (CHF) ranges from 50% to 80%. It has been established that ID is a significant predictor of adverse outcomes and mortality in CHF, and is also associated with a decrease in exercise tolerance. The use of oral iron preparations for the purpose of its correction is limited by the high frequency of adverse events and, in some cases, their ineffectiveness in CHF. Ferric carboxymaltose has a high potential in the correction of ID, which has proven itself well in the cohort of patients with CHF, but its effectiveness has not been precisely established in CHF.Aim: To evaluate the effect of ferric carboxymaltose therapy on the quality of life, functional status, and clinical picture of CHF in patients with diagnosed iron deficiency.Material and Methods. It is a prospective randomized cohort study. It is planned to include 70 adult patients with CHF (NYHA II-III) and diagnosed ID: group 1 (n = 35) - group of drug therapy with ferric carboxymaltose, group 2 (n = 35) - without drug therapy. A control group of patients without ID (n = 30) will also be recruited. The prospective part involves the observation of patients with repeated visits after 6, 12 months, during which the indicators of quality of life, functional status, clinical picture of CHF, structural and functional echocardiographic indicators of LV and right heart, as well as the presence of repeated hospitalizations for CHF and death from all causes will be evaluated.