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Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion

Study acronym: INFERRCT
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Enrollment target: 2000 to 1000v4 Show 5 more changesShow less
    • Primary and study completion dates: Jun 14, 2026 to Dec 31, 2026
    • Primary endpoints: 4 to 5
    • Study sites: 35 to 43
    • Secondary endpoints revised (5)
    • Eligibility criteria shortened, about 3 words
  2. Study sites: 29 to 35
    • Eligibility criteria revised
    v3
  3. Study sites: 15 to 29v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05759078
Lead Sponsor Wroclaw Medical University
Conditions
(from sponsor)		 Myocardial Infarction, Acute
Related terms Iron Deficiencies, Myocardial Infarction
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov