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Effect of intravenous ferric carboxymaltose on mortality and cardiovascular morbidity, and quality of life in iron deficient patients with recent myocardial infarction
EU CTIS ID: 2024-517206-28-00
What this study is testing
Evaluation of the effect of i.v. FCM treatment compared with placebo on the risk of death, the risk of heart failure events (HFE ) (number of events and time to first event), NTproBNP concentration and the change in quality of life (QoL) assessed using EQ-5D during the follow-up up to 36-months in patients with recent AMI and ID (with an implementation of a win ratio approach in a hierarchical descending order). HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).
- 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 ≥18 years.
- Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation.
- Presence of iron deficiency (ID) defined as transferrin saturation TSAT<20% assessed within up to 4 weeks (28 days) before randomisation.
- Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present): a. LVEF ≤50%; b. NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; c. Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; d. Diagnosis of diabetes mellitus (also de novo diagnosis); e. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); f. Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); g. Not complete revascularisation or/and no reperfusion (during an index AMI); h. History of AMI (despite an index AMI); i. eGFR <60 mL/min/1.73m2; j. Age ≥70 years.
- Written informed consent.
You likely can't join if
- Subject temperature >38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation.
- Subject has 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.
- Documented liver diseases.
- Participation in a device or drug trial within 3 months prior to randomisation or 5 half–lives, whichever period is longer, prior to the screening visit.
- Pregnancy or lactation.
- Any situation that may prevent the test from being performed in accordance with the protocol, or the consent of the investigator to be given in writing, including alcohol, drugs or any other substance overuse or addiction.
See the full eligibility criteria
- Age ≥18 years.
- Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation.
- Presence of iron deficiency (ID) defined as transferrin saturation TSAT<20% assessed within up to 4 weeks (28 days) before randomisation.
- Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present): a. LVEF ≤50%; b. NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; c. Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; d. Diagnosis of diabetes mellitus (also de novo diagnosis); e. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); f. Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); g. Not complete revascularisation or/and no reperfusion (during an index AMI); h. History of AMI (despite an index AMI); i. eGFR <60 mL/min/1.73m2; j. Age ≥70 years.
- Written informed consent.
- Subject temperature >38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation.
- Subject has 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.
- Documented liver diseases.
- Participation in a device or drug trial within 3 months prior to randomisation or 5 half–lives, whichever period is longer, prior to the screening visit.
- Pregnancy or lactation.
- Any situation that may prevent the test from being performed in accordance with the protocol, or the consent of the investigator to be given in writing, including alcohol, drugs or any other substance overuse or addiction.
- Severe, symptomatic valve disorder.
- Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
- Body weight <50 kg.
- Haemoglobin <8 g/dL or >15,5 g/dL.
- Serum ferritin >400 ng/mL.
- Active gastroenteral bleeding.
- Known hypersensitivity to any of the administered preparations.
- Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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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.