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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517206-28-00
Acronym
2019/ABM/01/00081
Enrollment
1000
Registered
2024-11-18
Start date
2022-09-21
Completion date
Unknown
Last updated
2024-11-18

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

Brief summary

1) Time to all-cause death assessed up to maximum 36-months follow-up;, 2) Number of HFE assessed up to maximum 36-months follow-up;, 3) Time to first HFE assessed up to maximum 36-months follow-up;, 4) Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve;, 5) Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve.

Detailed description

First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model)., All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model)., All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model)., All unplanned HF hospitalisations during the follow-up (recurrent event model)., CV death during thefollow-up.

Interventions

DRUG0
DRUG9% Sodium Chloride–Braun
DRUGFerinject 50 mg żelaza/ml dyspersja do wstrzykiwań/infuzji

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1) Time to all-cause death assessed up to maximum 36-months follow-up;, 2) Number of HFE assessed up to maximum 36-months follow-up;, 3) Time to first HFE assessed up to maximum 36-months follow-up;, 4) Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve;, 5) Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve.

Secondary

MeasureTime frame
First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model)., All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model)., All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model)., All unplanned HF hospitalisations during the follow-up (recurrent event model)., CV death during thefollow-up.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026