Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
- Conditions
- Myocardial Infarction, Acute
- Interventions
- Drug: Sodium Chloride 0.9% Inj
- Registration Number
- NCT05759078
- Lead Sponsor
- Wroclaw Medical University
- Brief Summary
Non-commercial, multicentre, randomised, double-blind, parallel group, placebo-controlled clinical trial. Eligible patients were randomly assigned (1:1) using a secure, central, interactive, web-based response system, to intervention FCM or placebo arm. Time of observation: minimum of 8 months up to a maximum of 36 months.
Primary Study Objective: Primary:
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
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Sodium Chloride 0.9% Inj 70 mL of i.v. NaCl 0.9% infusion Active Ferinject an i.v. 15-minute infusion of 20 mL Ferinject (containing 1000 mg of FCM) diluted in 50 mL of NaCl 0.9%
- Primary Outcome Measures
Name Time Method Time to all-cause death assessed up to maximum 36-months follow-up; up to 36 months Defined as: (with an implementation of a win ratio approach in a hierarchical descending order):
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.
* 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).Time to first HFE assessed up to maximum 36-months follow-up up to 36 months Time to first HFE
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 up to 36 months Changes in serum NT-proBNP
Number of HFE assessed up to maximum 36-months follow-up up to 36 months Number of HFE
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 up to 36 months Changes in quality of life
- Secondary Outcome Measures
Name Time Method CV death during the follow-up up to 36 months CV death
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model); up to 36 months All unplanned HF hospitalisations and unplanned visit at emergency
All unplanned HF hospitalisations during the follow-up (recurrent event model); up to 36 months All unplanned HF hospitalisations
First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model) up to 36 months First unplanned HF hospitalisation or unplanned visit at emergency
All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model) up to 36 months All unplanned HF hospitalisations and unplanned visit at emergency department
Trial Locations
- Locations (43)
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
🇵🇱Kraków, Poland
Wojewódzki Szpital Specjalistyczny w Legnicy
🇵🇱Legnica, Poland
Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej im. dr Wojciecha Oczko w Przasnyszu
🇵🇱Przasnysz, Poland
Wojewódzki Szpital im. Św. Ojca Pio
🇵🇱Przemyśl, Poland
Szpital Specjalistyczny Ducha Świętego w Sandomierzu
🇵🇱Sandomierz, Poland
Medicover Sp z o.o.
🇵🇱Warszawa, Poland
Szpital Specjalistyczny w Zabrzu Sp. z o.o.
🇵🇱Zabrze, Poland
Śląskie Centrum Chorób Serca w Zabrzu
🇵🇱Zabrze, Poland
Zespół Opieki Zdrowotnej w Kłodzku
🇵🇱Kłodzko, Dolnośląskie, Poland
Uniwersytecki Szpital kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
🇵🇱Wrocław, Dolnośląskie, Poland
Scroll for more (33 remaining)Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie🇵🇱Kraków, Poland