Intravenous iron infusion after transcatheter aortic valve implantation for people with iron deficiency
Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation: Study Protocol of the Randomized Controlled IRON-TAVI Trial
This trial will test whether an intravenous iron infusion after TAVI helps people aged 65 and older with severe aortic stenosis and iron deficiency feel better and walk farther.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 402 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT07370688 on ClinicalTrials.gov |
What this trial studies
IRON TAVI is an open-label, randomized controlled superiority trial that compares intravenous ferric carboxymaltose given after successful TAVI to standard care with no IV iron. Eligible participants are adults aged 65 or older with severe aortic stenosis and iron deficiency who can complete quality-of-life questionnaires and a six-minute walk test. Participants are randomized after informed consent, and the study measures health-related quality of life as the primary outcome and six-minute walk distance as a key secondary outcome at predefined follow-up visits. The design tests whether correcting iron deficiency in addition to valve replacement improves symptoms and functional capacity.
Who should consider this trial
Good fit: Ideal candidates are patients aged ≥65 undergoing successful TAVI who have iron deficiency (ferritin <100 µg/L and/or transferrin saturation <20%) and can perform QoL questionnaires and the six-minute walk test.
Not a fit: Patients without iron deficiency, those with anemia from other known causes, severe liver disease, dialysis-dependent kidney failure, or contraindications to ferric carboxymaltose are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, giving IV iron after TAVI could improve patients' quality of life and walking ability more than TAVI alone.
How similar studies have performed: Intravenous ferric carboxymaltose has improved symptoms and exercise capacity in heart failure patients with iron deficiency, but its effectiveness specifically after TAVI is less established and remains to be shown.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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.
Where this trial is running
Rotterdam, South Holland
- Erasmus University Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Rutger-Jan Nuis, MD, PhD
- Email: r.nuis@erasmusmc.nl
- Phone: +31614858291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.