Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis
Status:
Active, not recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Iron deficiency is a prevalent nutritional deficiency and a common cause of anemia. Although
iron deficiency is traditionally linked to anemia, iron deficiency is prevalent even in the
absence of anaemia and in itself limits function and survival. Iron deficiency is a common
feature of various chronic diseases, and up to 50% of patients with heart failure have iron
deficiency. Iron deficiency is more prevalent the more advanced the disease is and occurs
more frequently in women. Iron deficiency comprises absolute iron deficiency (usually defined
as ferritin < 100 ng/ml) as well as functional iron deficiency, in which iron supply is
inadequate to meet the demand for the production of red blood cells and other cellular
functions despite normal or abundant body iron stores. Iron deficiency is associated with
poor exercise capacity, lethargy and reduced quality of life. Results from our studies have
shown that iron deficiency is prevalent in patients with aortic stenosis. Some of the
symptoms associated with aortic stenosis, such as fatigue, reduced exercise capacity,
dyspnoea and cognitive dysfunction, have traditionally been thought to be caused by the
haemodynamic derangements precipitated by the valvular stenosis. However, similar symptoms
can be brought about by iron deficiency, and the investigators hypothesize that intravenous
iron supplement will improve exercise capacity, muscle strength, cognition, health-related
quality of life and myocardial function in patients with severe aortic stenosis and iron
deficiency. This is a phase 2, double blind, randomised, placebo-controlled trial.
Participants will be randomised in a 1:1 fashion to receive a single intravenous dose of iron
isomaltoside (50 patients) or matching placebo (50 patients). The study is designed to show
superiority with regard to the primary endpoint in patients assigned to active treatment
versus patients allocated to the placebo arm. The main goal is to evaluate the effect of a
single dose of intravenous iron isomaltoside on exercise capacity after transcatheter aortic
valve implantation in patients with severe aortic stenosis and iron deficiency. For this
study, the investigators have defined as serum ferritin < 100 µg/l or ferritin between 100
and 300 µg/l in combination with a transferrin saturation < 20 %.