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New treatment option for Aortic Valve Stenosis
Official title Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation
ClinicalTrials.gov ID: NCT07370688
What this study is testing
What is Intravenous ferric carboxymaltose?
Intravenous ferric carboxymaltose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aortic valve stenosis.
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
- The aim of the open-label, randomized controlled superiority IRON TAVI trial is to investigate whether intravenous iron therapy (ferric carboxymaltose) improves Health-Related Quality of Life (HRQOL) in patients with severe aortic stenosis (AS) and iron deficiency (ID), undergoing transcatheter aortic valve implantation (TAVI). The main questions it aims to answer are: 1.
- 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 65 and older
You may be able to join if
- Patient age ≥ 65 years
- Patients with severe AS and ID undergoing successful TAVI
- ID defined as Ferritin \< 100 ug/L and/or Transferrin saturation \< 20%
- Ability to perform assessment of QoL (questionnaire assessment) and EC (6-MWT)
- Signed Informed Consent
You likely can't join if
- Contra-indication for TAVI
- Ferritin \> 400 ug/L
- Hemoglobin \<5.6 mmol/L or \<9 g/dL
- Hemoglobin \>8.7 mmol/L or \>14 g/dL in men and \>8.1 mmol/L or \>13 g/dL in women
- Anaemia due to known reasons other than ID and/or anticipated non-response to iron-supplementation (e.g. hemogobinopathy, bone marow disease, active...
- Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit...
See the full eligibility criteria
- Patient age ≥ 65 years
- Patients with severe AS and ID undergoing successful TAVI
- ID defined as Ferritin \< 100 ug/L and/or Transferrin saturation \< 20%
- Ability to perform assessment of QoL (questionnaire assessment) and EC (6-MWT)
- Signed Informed Consent
- Contra-indication for TAVI
- Ferritin \> 400 ug/L
- Hemoglobin \<5.6 mmol/L or \<9 g/dL
- Hemoglobin \>8.7 mmol/L or \>14 g/dL in men and \>8.1 mmol/L or \>13 g/dL in women
- Anaemia due to known reasons other than ID and/or anticipated non-response to iron-supplementation (e.g. hemogobinopathy, bone marow disease, active cancer, unresolved active bleeding)
- Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.
- Renal dialysis (previous, current, or planned within the next 6 months) or MDRD/CKD-EPI estimated glomerular filtration rate \<15 mL/min.
- History of iron overload
- History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 3 months and/or such therapy planned within next 6 months
- Clinically apparent infection requiring antibiotic treatment
- Known hypersensitivity to iFCM or to any of its excipients
- Pregnancy
- Study subject participation in another TAVI related clinical study in which the primary endpoint includes mortality, hospitalization for heart failure and/or quality of life assessment.
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, South Holland, Netherlands. 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.