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A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

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Trial Profile

A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 29 Oct 2024

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At a glance

  • Drugs Ferric carboxymaltose (Primary)
  • Indications Heart failure; Iron deficiency anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CONFIRM-HF
  • Sponsors Vifor

Most Recent Events

  • 05 Jun 2023 According to a Daiichi Sankyo Company media release, the U.S. Food and Drug Administration (FDA) approved INJECTAFER (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association class II/III to improve exercise capacity, based on data from this trial.
  • 13 Mar 2022 Results of pooled analysis from FAIR-HF and CONFIRM-HF assessing whether Treatment of iron-deficient HFrEF patients with intravenous FCM conveyed clinically relevant improvements in health status at an individual-patient level, published in the European Journal of Heart Failure
  • 23 May 2016 Results published in Vifor Pharma media release.

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