NCT05793996 The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
| NCT ID | NCT05793996 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences |
| Condition | Chronic Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-04-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2023-04-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Alla A. Garganeeva, M.D.
PRINCIPAL INVESTIGATOR
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Frequently Asked Questions
Who can join the NCT05793996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05793996 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05793996 currently recruiting?
Yes, NCT05793996 is actively recruiting participants. Contact the research team at olgatukish@yandex.ru for enrollment information.
Where is the NCT05793996 trial being conducted?
This trial is being conducted at Tomsk, Russia.
Who is sponsoring the NCT05793996 clinical trial?
NCT05793996 is sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. The principal investigator is Alla A. Garganeeva, M.D. at Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences. The trial plans to enroll 100 participants.
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