NCT05793996RecruitingPhase 4
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
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
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 1 Mar 2023
- Start date
- 28 Apr 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Diseases
- Heart failure
- NCT number
- NCT05793996
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 28 Apr 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Blood transfusions and taking erythropoiesis-stimulating drugs during the previous three months.
Other illness
- Uncontrolled arterial hypertension;
- 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;
- Known active infection, clinically significant bleeding, active malignancy;
- Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.);
- Allergic reactions to medications in the anamnesis, eczema, atopic allergic reaction;
Lab values
- Аnemia with a hemoglobin level of less than 90 g/l;
- 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);
Other
- Аnemia not related to iron deficiency;
- Severe bronchial asthma, COPD in the acute stage;
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences Coordinator of this site? Confirm its status | Tomsk | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.