Evaluation of carboxymaltose treatment in patients with myocardial infarction associated with iron deficiency

Effect of Intravenous FERRic carboxymaltose on mortality and cardiovascular morbidity, and quality of life in iron deficient patients with recent myocardial infarction - INFERRCT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005740-27-PL

Enrollment

1000

Registered

2021-01-11

Start date

2021-04-19

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recent myocardial infarction associated with iron deficient MedDRA version: 27.1 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Ferinject 50 mg Fe3+/mL, Solution for injection/infusion Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age =18 years; 2) Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks before radomisation; 3) Presence of iron deficiency (ID) defined as transferrin saturation TSAT=65 years) yes F.1.3.1 Number of subjects for this age range 600

Exclusion criteria

Exclusion criteria: 1) Subject temperature>38 ? C or any infection requiring antibiotic therapy within 48 hours prior to randomisation. 2) Severe, symptomatic valvular disorder. 3) Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation). 4) Body weight 15,5g/dL. 6) Serum ferritin>400 ng/mL. 7) TSAT>40%. 8) Active gastroenteral bleeding. 9) 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. 13) 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of intravenous (i.v.) treatment with ferric carboxymaltose (FCM) versus placebo in patients after myocardial infarction and iron deficiency on total mortality, risk of developing heart failure events* (assessed as number of events and time to first event), NT-proBNP levels, and quality of life as measured by the EQ-5D questionnaire during follow-up up to 36 months.;Secondary Objective: - presence of a composite primary endpoint and other clinical events (unplanned hospitalization for heart failure, unplanned emergency department visit for heart failure, outpatient intensified diuretic treatment [meaning inclusion of intravenous loop diuretic therapy or more than doubling of oral diuretic dose or de novo initiation of oral loop diuretic therapy due to heart failure symptoms], unplanned hospitalizations for cardiovascular causes, all-cause, cardiovascular and non-cardiovascular deaths, separately and in combination); - change in quality of life (QoL) as measured by the EQ-5D questionnaire during the participant's participation in the study; - change in NT-proBNP concentration during the participant's participation in the study; - safety; and tolerability.;Primary end point(s): 1) Time to death from any cause assessed during maximum 36-month follow-up; 2) Number of heart failure events* assessed during a maximum 36-month follow-up; 3) Time to first heart failure event* assessed during maximum 36-month follow-up; 4) Changes in plasma NT-proBNP concentration from the start of follow-up to the end of study participation assessed as area under the curve; 5) Changes in quality of life (QoL) measured by the EQ-5D questionnaire from start of follow-up end of study participation assessed as areas under the curve.;Timepoint(s) of evaluation of this end point: Points 1 2 3 5at a minimum of 8 months to 36 months follow-up. Point 4 at 8, 12, 24 and 36 months.	—

Measure

Time frame

Main Objective: To evaluate the effect of intravenous (i.v.) treatment with ferric carboxymaltose (FCM) versus placebo in patients after myocardial infarction and iron deficiency on total mortality, risk of developing heart failure events* (assessed as number of events and time to first event), NT-proBNP levels, and quality of life as measured by the EQ-5D questionnaire during follow-up up to 36 months.;Secondary Objective: - presence of a composite primary endpoint and other clinical events (unplanned hospitalization for heart failure, unplanned emergency department visit for heart failure, outpatient intensified diuretic treatment [meaning inclusion of intravenous loop diuretic therapy or more than doubling of oral diuretic dose or de novo initiation of oral loop diuretic therapy due to heart failure symptoms], unplanned hospitalizations for cardiovascular causes, all-cause, cardiovascular and non-cardiovascular deaths, separately and in combination); - change in quality of life (QoL) as measured by the EQ-5D questionnaire during the participant's participation in the study; - change in NT-proBNP concentration during the participant's participation in the study; - safety; and tolerability.;Primary end point(s): 1) Time to death from any cause assessed during maximum 36-month follow-up; 2) Number of heart failure events* assessed during a maximum 36-month follow-up; 3) Time to first heart failure event* assessed during maximum 36-month follow-up; 4) Changes in plasma NT-proBNP concentration from the start of follow-up to the end of study participation assessed as area under the curve; 5) Changes in quality of life (QoL) measured by the EQ-5D questionnaire from start of follow-up end of study participation assessed as areas under the curve.;Timepoint(s) of evaluation of this end point: Points 1 2 3 5at a minimum of 8 months to 36 months follow-up. Point 4 at 8, 12, 24 and 36 months.

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Secondary

Measure	Time frame
Secondary end point(s): 1) First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up up to 12-months (time-to-event model); 2) All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up up to 12 months (recurrent event model); 3) All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up up to 12 months (recurrent event model); 4) All unplanned HF hospitalisations during the follow-up up to 12 months (recurrent event model); 5) CV death during the follow-up up to 12 months. Other efficacy outcomes: 1) First unplanned hospitalization for cardiovascular reasons or death from cardiovascular causes during follow-up (model assessing time to first event). 2) All unplanned hospitalizations for cardiovascular reasons or death from cardiovascular causes during follow-up (multiple event model). 3) All unplanned hospitalizations for cardiovascular reasons during follow-up (multiple event model); 4) Death from other causes (non-cardiovascular) during follow-up. 5) Death from any cause during follow-up. 6) Intensification of loop diuretic treatment in the outpatient setting, understood as the use of intravenous diuretic therapy or more than doubling the dose of oral diuretic or starting oral loop diuretic therapy due to the onset of clinical symptoms of heart failure during follow-up. 7) Changes in plasma NT-proBNP concentration assessed as area under the curve during follow-up. 8) Changes in quality of life (QoL) measured by the EQ-5D questionnaire assessed as areas under the curve during follow-up. 9) Evaluation of the cost-effectiveness of the study.;Timepoint(s) of evaluation of this end point: Points 1-6 and 8-9 at a minimum of 8 months to 36 months of follow-up. Item 7 at 8,12, 24 and 36 months.	—

Measure

Time frame

Secondary end point(s): 1) First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up up to 12-months (time-to-event model); 2) All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up up to 12 months (recurrent event model); 3) All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up up to 12 months (recurrent event model); 4) All unplanned HF hospitalisations during the follow-up up to 12 months (recurrent event model); 5) CV death during the follow-up up to 12 months. Other efficacy outcomes: 1) First unplanned hospitalization for cardiovascular reasons or death from cardiovascular causes during follow-up (model assessing time to first event). 2) All unplanned hospitalizations for cardiovascular reasons or death from cardiovascular causes during follow-up (multiple event model). 3) All unplanned hospitalizations for cardiovascular reasons during follow-up (multiple event model); 4) Death from other causes (non-cardiovascular) during follow-up. 5) Death from any cause during follow-up. 6) Intensification of loop diuretic treatment in the outpatient setting, understood as the use of intravenous diuretic therapy or more than doubling the dose of oral diuretic or starting oral loop diuretic therapy due to the onset of clinical symptoms of heart failure during follow-up. 7) Changes in plasma NT-proBNP concentration assessed as area under the curve during follow-up. 8) Changes in quality of life (QoL) measured by the EQ-5D questionnaire assessed as areas under the curve during follow-up. 9) Evaluation of the cost-effectiveness of the study.;Timepoint(s) of evaluation of this end point: Points 1-6 and 8-9 at a minimum of 8 months to 36 months of follow-up. Item 7 at 8,12, 24 and 36 months.

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Countries

Poland

Contacts

Public ContactUCWBK

Uniwersyteckie Centrum Wsparcia Badan Klinicznych Uniwersytetu Medycznego im. Piastów Slaskich we Wroclawiu

rnc@umw.edu.pl0048717840698

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026