Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion SUBTITLE Prevention of Cardiovascular Death, Heart Failure Events and Deterioration in Quality of Life With INtravenous FERRic Carboxymaltose in Iron Deficient Patients With Recent Myocardial Infarction
Wroclaw Medical University
1,000 participants
Sep 22, 2022
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The first dose of either FCM will be administered during the first visit on the day of randomisation (V1). Then, the participants will be reassessed at 4, 8, 12, 18, 24 and 30 months (visits V2, V3, V4, V5, V6, V7). If safety criteria are not fulfilled, a patient in the active study arm will receive i.v. NaCl 0.9% during the particular visit.
The first dose of placebo will be administered during the first visit on the day of randomisation (V1). Then, the participants will be reassessed at 4, 8, 12, 18, 24 and 30 months (visits V2, V3, V4, V5, V6, V7).
Locations(43)
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NCT05759078