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Clinical trial assessing the effect of intravenous versus oral iron supplementation on physical performance, quality of life and cognitive function in elderly frail iron deficient individuals with cardiovascular disease
EU CTIS ID: 2025-521570-34-00
What this study is testing
To evaluate the effect of intravenous iron (ferric carboxymaltose, FCM) compared with oral iron (ferrous sulphate, FS) and placebo on physical performance, measured by the Short Physical Performance Battery (SPPB), in older adults with physical frailty and iron deficiency over a 12-month treatment period.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥65 years
- Diagnosis of CVD, i.e. defined as at least one of the following diseases: pharmacologically treated AH, AF, HF, CAD confirmed by either coronary revascularisation or previous myocardial infarction, CBVD confirmed by either cerebral revascularisation or previous stroke, PAD confirmed by either peripheral artery revascularisation or previous acute limb ischaemia;
- Frailty status confirmed as ≥5/15 points in TFI
- Poor or moderate physical performance confirmed as ≤9/12 points in SPPB
- Iron deficiency (ID) defined as TSAT<20%
- Provided written informed consent
You likely can't join if
- Bed-bound status
- Vitamin D3 deficiency without effective supplementation
- Documented liver disease and/or AST or ALT above 3-fold upper laboratory limit or active hepatitis B (HBV) or hepatitis C (HCV) infection, including ongoing antiviral treatment
- Known hypersensitivity to any of administered preparations or any of their excipients
- Treatment with erythropoiesis stimulating factors, iv iron ther-apy and/or blood transfusion within 6 months prior to screening
- Clinical indication that any of these treatments, i.e. erythro-poiesis stimulating factors, i.v./oral iron supplementation and/or blood transfusion, is recommended and should be administered (e.g. severe symptomatic anaemia, chronic kidney disease requir-ing renal replacement therapy)
See the full eligibility criteria
- Age ≥65 years
- Diagnosis of CVD, i.e. defined as at least one of the following diseases: pharmacologically treated AH, AF, HF, CAD confirmed by either coronary revascularisation or previous myocardial infarction, CBVD confirmed by either cerebral revascularisation or previous stroke, PAD confirmed by either peripheral artery revascularisation or previous acute limb ischaemia;
- Frailty status confirmed as ≥5/15 points in TFI
- Poor or moderate physical performance confirmed as ≤9/12 points in SPPB
- Iron deficiency (ID) defined as TSAT<20%
- Provided written informed consent
- Ability to comply with study treatment regimen and complete study assessments and questionnaires himself/herself
- Bed-bound status
- Vitamin D3 deficiency without effective supplementation
- Documented liver disease and/or AST or ALT above 3-fold upper laboratory limit or active hepatitis B (HBV) or hepatitis C (HCV) infection, including ongoing antiviral treatment
- Known hypersensitivity to any of administered preparations or any of their excipients
- Treatment with erythropoiesis stimulating factors, iv iron ther-apy and/or blood transfusion within 6 months prior to screening
- Clinical indication that any of these treatments, i.e. erythro-poiesis stimulating factors, i.v./oral iron supplementation and/or blood transfusion, is recommended and should be administered (e.g. severe symptomatic anaemia, chronic kidney disease requir-ing renal replacement therapy)
- Known active malignancy of any organ system, i.e. clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
- Participation in a device or drug trial within 3 months prior to screening or 5 half-lives, whichever period is longer, prior to screening
- Any situation that may prevent the investigations from being performed in accordance with the trial protocol
- Body weight below 35 kg
- Diagnosis of dementia requiring the therapy with anti-dementia drugs
- Diagnosis of depression requiring the therapy with anti-depres-sive drugs
- Urgent or elective hospitalisation for whatever reasons (includ-ing percutaneous/surgical procedure requiring hospitalisation) within 4 weeks prior to screening
- Subject temperature >38°C, or any infection requiring antibi-otic therapy within one week prior to screening
- Haemoglobin <10 g/dL or >15 g/dL
- Serum ferritin >400 ng/mL
- Vitamin B12 and/or folic acid deficiency without effective sup-plementation
The study team makes the final eligibility decision.
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. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.