Observational cohort randomized controlled study to study the influence of correction of ID by intravenous injection of ferric carboxymaltose (Ferinject®) on quality of life indicators, functional status in a cohort of patients with HFpEF.
Signed informed consent to participate in the study;
In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF);
Left ventricular ejection fraction (LVEF) ≥50%; objective signs of structural and/or functional disorders of the heart consistent with the presence of LV diastolic dysfunction/increased LV filling pressure, including elevated levels of natriuretic peptide;
Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%;
Uncontrolled arterial hypertension;
Аnemia not related to iron deficiency;
Аnemia with a hemoglobin level of less than 90 g/l;
Less than 1 year after acute myocardial infarction;
Parallel
Ferinject
DrugThe calculation of the dose of iron carboxymaltosate (Ferinject ® preparation) for the purpose of correction of iron will be carried out on the basis of the following step-by-step approach: determination of individual iron needs, calculation and administration of iron dose, assessment of the saturation of the patient's body with iron 6 weeks after infusion.
Diet therapy
Other interventionPatients will receive diet therapy to correct latent iron deficiency
Primary Outcome (Combined)
Change of 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ) (0-100 points)+change in test distance with a 6-minute walk (6MWD - 150 meters or more) by 35 meters or more. An increase in the number of points by 5 on the Kansas City Cardiomyopathy Questionnaire scale, increasing the distance on the 6-minute walk test by 35 meters means a better result. The absence of changes/decrease in the number of points on the Kansas City Cardiomyopathy Questionnaire scale, the absence of changes/decrease in the distance in the 6-minute walking test means the worst result.
Changing by 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ 0-100 points)
Change of 5 or more points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) (0-100 points). An increase in the number of points by 5 on the Kansas City Cardiomyopathy Questionnaire scale means a better result. The absence of changes/decrease in the number of points on the Kansas City Cardiomyopathy Questionnaire scale means the worst result.
Changing in test distance with a 6-minute walk (6MWD 300 meters or more) of 35 meters
Change in the distance when testing a 6-minute walk by 35 meters or more. An increase the distance on the 6-minute walk test by 35 meters or more means a better result. The absence of changes/decrease in the distance in the 6-minute walking test means the worst result.
Changing functional class of chronic heart failure (CHF) by New York Heart Association (NYHA I-IV functional classes)
Reduction of the functional class of CHF according to New York Heart Association by 1point means a better result. No changes or an increase in the functional class means a worse result.
Hospitalization for heart failure and death from all causes
The absence of hospitalizations for heart failure and death from all causes means a better result. Hospitalization and death from all causes means the worst result.
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