The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)

Официальное название

Study of the Prevalence of Iron Deficiency Among Hospitalized Patients With HFpEF and the Impact of Ferinject® on Indicators of Quality of Life, Functional Status in Patients With Iron Deficiency

Обзор

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.

Подробное описание

The prevalence of HFpEF among patients admitted to cardiology hospitals will be studied. The study will include patients with NYHA II-III who have signed an informed consent that meets the inclusion/exclusion criteria. The effectiveness of intravenous administration of iron carboxymaltose (Ferinject ® ) to correct iron deficiency and improve the clinical course of HFpEF will be evaluated. A group without iron deficiency will be recruited as a control group (n=30).

Вмешательства

• Препарат Ferinject
  The 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.
• Другое Diet therapy
  Patients will receive diet therapy to correct latent iron deficiency

Первичные конечные точки

• Primary Outcome (Combined) [Срок оценки: 12 months]

Вторичные конечные точки (5)

• Changing by 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ 0-100 points) [Срок оценки: 6 months]
• Changing in test distance with a 6-minute walk (6MWD 300 meters or more) of 35 meters [Срок оценки: 6 months]
• Changing functional class of chronic heart failure (CHF) by New York Heart Association (NYHA I-IV functional classes) [Срок оценки: 6 months]
• Hospitalization for heart failure and death from all causes [Срок оценки: 12 months]
• Changing by 5 or more points according to the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) (0-105 points). [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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%;
• Screening haemoglobin (Hb) at the time of switching on ( 90-150 g/l).

Критерии исключения

• 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;
• Less than 1 year after acute cerebral circulation disorder;
• Less than 1 year after surgical interventions, including non-cardiac operations and myocardial revascularization (coronary bypass surgery, coronary artery stenting), operations for valvular pathology;
• Chronic alcoholism (including alcoholic heart disease), mental disorders;
• Severe hepatic (increased transaminase levels above the upper three limits of normal) and renal insufficiency (glomerular filtration rate less than 15 ml/min/1.73 m2);
• Known active infection, clinically significant bleeding, active malignancy;
• Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.);
• Severe bronchial asthma, COPD in the acute stage;
• Allergic reactions to medications in the anamnesis, eczema, atopic allergic reaction;
• Blood transfusions and taking erythropoiesis-stimulating drugs during the previous three months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of — Tomsk

Идентификаторы

NCT: NCT05793996 · CRI-243

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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