Effect of intravenous ferric carboxymaltose on mortality and cardiovascular morbidity, and quality of life in iron deficient patients with recent myocardial infarction
- Conditions
- Recent myocardial infarction associated with iron deficient
- Registration Number
- 2024-517206-28-00
- Lead Sponsor
- Wroclaw Medical University
- Brief Summary
Evaluation of the effect of i.v. FCM treatment compared with placebo on the risk of death, the risk of heart failure events (HFE*) (number of events and time to first event), NTproBNP concentration and the change in quality of life (QoL) assessed using EQ-5D during the follow-up up to 36-months in patients with recent AMI and ID (with an implementation of a win ratio approach in a hierarchical descending order). *HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 1000
Age ≥18 years.
Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation.
Presence of iron deficiency (ID) defined as transferrin saturation TSAT<20% assessed within up to 4 weeks (28 days) before randomisation.
Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present): a. LVEF ≤50%; b. NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; c. Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; d. Diagnosis of diabetes mellitus (also de novo diagnosis); e. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); f. Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); g. Not complete revascularisation or/and no reperfusion (during an index AMI); h. History of AMI (despite an index AMI); i. eGFR <60 mL/min/1.73m2; j. Age ≥70 years.
Written informed consent.
Subject temperature >38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation.
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.
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.
Pregnancy or lactation.
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.
Severe, symptomatic valve disorder.
Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
Body weight <50 kg.
Haemoglobin <8 g/dL or >15,5 g/dL.
Serum ferritin >400 ng/mL.
Active gastroenteral bleeding.
Known hypersensitivity to any of the administered preparations.
Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Time to all-cause death assessed up to maximum 36-months follow-up; 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; 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; 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; 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. 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 Outcome Measures
Name Time Method First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model). 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 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 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). All unplanned HF hospitalisations during the follow-up (recurrent event model).
CV death during thefollow-up. CV death during thefollow-up.
Trial Locations
- Locations (29)
American Heart Of Poland S.A.
🇵🇱Kedzierzyn-Kozle, Poland
Centrum Opieki Medycznej
🇵🇱Jaroslaw, Poland
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
🇵🇱Przemysl, Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
🇵🇱Wroclaw, Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
🇵🇱Torun, Poland
Medicover Integrated Clinical Services Sp. z o.o.
🇵🇱Warsaw, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Slaskie Centrum Chorob Serca W Zabrzu
🇵🇱Zabrze, Poland
Uniwersytecki Szpital Kliniczny W Opolu
🇵🇱Opole, Poland
Wojewodzki Szpital Specjalistyczny W Legnicy
🇵🇱Legnica, Poland
Scroll for more (19 remaining)American Heart Of Poland S.A.🇵🇱Kedzierzyn-Kozle, PolandKrzysztof MilewskiSite contact609109131krzysztof.milewski@ahop.plAleksander ŻurakowskiSite contact605336127olekzurakowski@gmail.comAdam JanasSite contact602332935adam.janas@ahop.plJanusz ProkopczukSite contact774722565janusz.prokopczuk@ahop.pl