Iron Infusion in Elderly Patients undergoing Transcatheter Aortic Valve Implantation (IRON TAVI) Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Decision date (initial)

2023-12-07

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Erasmus University Medical Center · Vifor Pharma

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To determine whether intravenous iron (ferric carboxymaltose) would improve Quality of life and Exercise Capacity in patients with severe Aortic Stenosis and Iron Deficiency undergoing TAVI

Conditions and MedDRA coding

Patients with Aortic stenosis and Iron deficiency

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patient age ≥ 65 years.
2. Patients with severe aortic stenosis and iron deficiency undergoing successful TAVI
3. Iron deficiency defined as Ferritin < 100 ug/L and/or Transferrin saturation < 20%
4. Ability to perform assessment of quality of life (questionnaire assessment), exercise capacity (6-minute walk test) and cognitive function assessment (questionnaire assessment).
5. Signed Informed Consent

Exclusion criteria 13

1. Contra-indication for transfemoral TAVI
2. Ferritin > 400 ug/L
3. Hemoglobin <5.6 mmol/L or <9 g/dL
4. Hemoglobin >8.7 mmol/L or >14 g/dL in men and >8.1 mmol/L or >13 g/dL in women
5. 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)
6. Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.
7. Renal dialysis (previous, current, or planned within the next 6 months) or MDRD/CKD-EPI estimated glomerular filtration rate <15 mL/min.
8. History of iron overload
9. 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
10. Clinically apparent infection requiring antibiotic treatment
11. Known hypersensitivity to iFCM or to any of its excipients
12. Pregnancy
13. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Quality of life at 6 months (using the 23-item Kansas City Cardiomyopathy Questionnaire, KCCQ-23, as continuous variable)
2. Exercise capacity at 6 months (using 6-minute walk test, 6-MWT as continuous variable).

Secondary endpoints 7

1. Cognitive function at 6 months (using the Mini Mental State Examination, MMSE as continuous variable).
2. NYHA classification at 6 months (as continuous variable).
3. Patient Global Assessment at 6 months (as continuous variable).
4. European Quality of Life-5 Dimensions Utility Index (EQ-5D-UI) and Visual Analog Scale (EQ-5D-VAS) at 6 months (as continuous variable).
5. Composite of cardiovascular mortality and heart failure hospitalizations at 6 months
6. All-cause mortality at 6 months
7. Favourable quality of life (survival with KCCQ-score ≥60 without KCCQ-decline >10 points from baseline to follow-up) at 6 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Dr RJ Nuis

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Dr RJ Nuis

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

2 submissions — initial application plus substantial / non-substantial modifications