Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion

Launched by WROCLAW MEDICAL UNIVERSITY · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Ferric Carboxymaltose (FCM), which is given through an IV, on patients who have recently had a heart attack (known as a myocardial infarction) and are also iron deficient. The main goals are to see if FCM can lower the risk of heart-related problems, like heart failure or death, and to improve the quality of life for these patients over a period of 12 months.

To be eligible for this trial, participants must be at least 18 years old and have experienced a heart attack within the last four weeks. They also need to show signs of iron deficiency and have certain heart issues or health conditions. Participants will be randomly assigned to receive either the FCM treatment or a placebo (a harmless substance with no therapeutic effect) for the study duration. Throughout the trial, participants will be monitored for heart-related events and changes in their quality of life, ensuring they receive appropriate care. This trial may provide valuable information about how to better manage heart health in patients dealing with iron deficiency after a heart attack.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years;
• • 2. Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks before randomisation;
• • 3. Presence of iron deficiency (ID) defined as transferrin saturation TSAT\<20% and/or serum ferritin \<100 ng/mL assessed up to 4 weeks 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;
• • 10. 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 g/dL;
• • 6. Serum ferritin \>400 ng/mL;
• • 7. TSAT \>40 %;
• • 8. Active gastroenteral bleeding;
• • 9. Known hypersensitivity to any of the administered preparations;
• • 10. Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation;
• • 11. 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;
• • 12. 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;
• • 14) Pregnancy or lactation; 15) 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.