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Recruiting Phase 4 NCT05793996

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

Trial Parameters

Condition Chronic Heart Failure
Sponsor Tomsk National Research Medical Center of the Russian Academy of Sciences
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-04-28
Completion 2026-12
Interventions
FerinjectDiet therapy

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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). Exclusion Criteria: * 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 revasc

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