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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Vitamed Bydgoszcz
  Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland Recruiting
• Regionalny Szpital Specjalistyczny im. dr Wł. Biegańskiego w Grudziądzu
  Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland Recruiting
• Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
  Torun, Kuyavian-Pomeranian Voivodeship, Poland Recruiting
• Polsko-Amerykańskie Kliniki Serca Małopolskie Centrum Sercowo-Naczyniowe
  Chrzanów, Lesser Poland Voivodeship, Poland Recruiting
• Szpital Specjalistyczny im. J. Dietla w Krakowie
  Krakow, Lesser Poland Voivodeship, Poland Recruiting
• Medicome Sp. z o.o.
  Oświęcim, Lesser Poland Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Piotr Ponikowski — Wroclaw Medical University
• Study coordinator: Marta Duda-Sikuła
• Email: marta.duda-sikula@umw.edu.pl
• Phone: 717840696

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.