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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

About this trial

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

Qualifiers

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%;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Ferinject
  • Diet therapy

Treatment groups

100 Participants
are divided into 3 treatment groups