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Tests treatment safety and results for Chronic Heart Failure
Official title The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
ClinicalTrials.gov ID: NCT05793996
What this study is testing
What is Ferinject?
Ferinject is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic heart failure.
Also referred to as Ferric carboxymaltose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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...
See the full eligibility 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...
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tomsk, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tomsk, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.