Phase 4 Cardiomyopathy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 65 years or older
- People who have severe aortic valve narrowing (a heart valve problem) combined with iron deficiency, and who have successfully undergone a TAVI procedure (a minimally invasive heart valve replacement)
- People whose iron deficiency is confirmed by specific blood test results showing low iron stores (ferritin below 100 ug/L and/or transferrin saturation below 20%)
- People who are able to complete a quality-of-life questionnaire and a walking test (a 6-minute walk test)
- People who have signed a consent form agreeing to take part
Who may not be able to join:
- People for whom a TAVI procedure is medically not suitable
- People with a ferritin blood level above 400 ug/L
- People whose haemoglobin (a measure of red blood cells) is too low (below 9 g/dL)
- People whose haemoglobin is too high (above 14 g/dL for men or above 13 g/dL for women)
- People whose anaemia (low red blood cell levels) is caused by a known condition other than iron deficiency, such as a blood disorder, bone marrow disease, active cancer, or ongoing bleeding
- People with chronic liver disease (including active hepatitis) or abnormal liver blood test results above a certain level
- People currently on kidney dialysis, who have previously been on dialysis, or who are expected to need dialysis within the next 6 months, or whose kidney function test result is very low (below 15 mL/min) (confirm with trial site)
- People with a history of having too much iron in their body (iron overload)
- People who have received erythropoietin, iron therapy (by injection or tablet), or a blood transfusion in the past 3 months, or who have any of these treatments planned in the next 6 months
- People who currently have an active infection being treated with antibiotics
- People with a known allergy or sensitivity to the study medication (iFCM) or any of its ingredients
- People who are pregnant
- People already participating in another clinical study related to TAVI where the main outcomes being measured include death, heart failure hospitalisation, or quality of life
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: +31614858291
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in Health-related Quality of Life (HRQOL); Change in 6-Minute Walk Test (6-MWT)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.