Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT04206228
Eligibility Criteria:
Inclusion Criteria:
* Aortic stenosis patients with peak flow velocity (\>3.5 m/s) scheduled for aortic valve replacement with TAVI
* Iron deficiency defined as serum ferritin \< 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation \< 20 %.
* Age \> 18 years.
* Signed informed consent and expected compliance with protocol.
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
* Anaemia (Haemoglobin \< 100 mg/l)
* Haemochromatosis
* Haemosiderosis
* Porphyria cutanea tarda
* Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
* Decompensated liver disease (Child-Pugh score 7 or higher)
* End-stage renal failure, i.e. eGFR \< 15 ml/min or on renal replacement therapy
* Planned major surgery within 6 months
* On erythropoietin analogues
* Known sensitivity or intolerance to iron isomaltoside or other parenteral iron preparations
* Intravenous iron supplement within 6 months prior to inclusion
* A clear indication for intravenous iron supplement
* On oral iron substitution (unless the subject agrees to stop treatment prior to randomisation)
* Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
* Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up
* Failure to obtain written informed consent
* Inability to walk at least 100 meters over 6 minutes
* Women of child-bearing potential (1)
1. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Menopause is defined as 12 months continuous amenorrhea without an alternative medical cause in a female ≥ 55 years old or 12 months of spontaneous and continuous amenorrhea with a follicle stimulating hormone (FSH) level \> 40 IU/L (or according to the definition of "postmenopausal range" for the laboratory involved) in a female \< 55 years old unless the subject has undergone bilateral oophorectomy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04206228
Study Brief:
Protocol Section:
NCT04206228