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Effect of intravenous iron treatment on heart health and quality of life in patients with recent heart attacks and iron deficiency

Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion SUBTITLE Prevention of Cardiovascular Death, Heart Failure Events and Deterioration in Quality of Life With INtravenous FERRic Carboxymaltose in Iron Deficient Patients With Recent Myocardial Infarction

Phase 4 Interventional Wroclaw Medical University · NCT05759078

This study is testing if giving intravenous iron to people with recent heart attacks and low iron levels can improve their heart health and quality of life.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years to 90 Years
SexAll
SponsorWroclaw Medical University Academic / other
Locations43 sites (Bydgoszcz, Kuyavian-Pomeranian Voivodeship and 42 other locations)
Trial IDNCT05759078 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the impact of intravenous ferric carboxymaltose (FCM) on mortality, cardiovascular morbidity, and quality of life in patients who have experienced an acute myocardial infarction (AMI) and have iron deficiency. It is a multicenter, randomized, double-blind, placebo-controlled study where eligible participants are assigned to receive either FCM or a placebo. The primary objectives include assessing the risk of cardiovascular death and heart failure events over a 12-month follow-up period, as well as measuring changes in quality of life using the EQ-5D scale. The study aims to provide insights into the benefits of iron supplementation in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have had a recent acute myocardial infarction and are diagnosed with iron deficiency.

Not a fit: Patients who do not have iron deficiency or who have not experienced a recent myocardial infarction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce cardiovascular complications and improve the quality of life for patients recovering from a heart attack with iron deficiency.

How similar studies have performed: Other studies have shown promising results with intravenous iron treatments in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

1. Age ≥18 years;
2. Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation
3. Presence of iron deficiency (ID) defined as transferrin saturation TSAT\<20% assessed within up to 4 weeks (28 days) before randomisation;
4. Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present):

   1. LVEF ≤50%;
   2. NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation;
   3. Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use;
   4. Diagnosis of diabetes mellitus (also de novo diagnosis);
   5. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis);
   6. Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI);
   7. Not complete revascularisation or/and no reperfusion (during an index AMI);
   8. History of AMI (despite an index AMI);
   9. eGFR \<60 mL/min/1.73m2; 1. Age ≥70 years.
5. Written informed consent

Exclusion criteria:

1. Subject temperature \>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation;
2. Severe, symptomatic valve disorder;
3. Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
4. Body weight \<50 kg;
5. Haemoglobin \<8 g/dL or \>15,5 g/dL;
6. Serum ferritin \>400 ng/mL;
7. Active gastroenteral bleeding;
8. Known hypersensitivity to any of the administered preparations;
9. Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation;
10. 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;
11. Documented liver diseases;
12. 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;
13. Pregnancy or lactation;
14. 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.

Where this trial is running

Bydgoszcz, Kuyavian-Pomeranian Voivodeship and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Myocardial Infarction, AcuteMyocardial infarctionacuteiron deficiencyInfusionferric carboxymaltose
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.