University of Hertfordshire

By the same authors

  • PIVOTAL investigators and committees
  • Pardeep S Jhund
  • Mark C Petrie
  • Michele Robertson
  • Patrick B Mark
  • Michael R MacDonald
  • Eugene Connolly
  • Stefan D Anker
  • Sunil Bhandari
  • Kenneth Farrington
  • Philip A Kalra
  • David C Wheeler
  • Charles R V Tomson
  • Ian Ford
  • John J V McMurray
  • Iain C Macdougall
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Original languageEnglish
Pages (from-to)518-527
Number of pages10
JournalJACC. Heart failure
Early online date9 Jun 2021
Publication statusPublished - 1 Jul 2021


Objectives: This study sought to examine the effect of intravenous iron on heart failure events in hemodialysis patients.

Background: Heart failure is a common and deadly complication in patients receiving hemodialysis and is difficult to diagnose and treat.

Methods: The study analyzed heart failure events in the PIVOTAL (Proactive IV Iron Therapy in Hemodialysis Patients) trial, which compared intravenous iron administered proactively in a high-dose regimen with a low-dose regimen administered reactively. Heart failure hospitalization was an adjudicated outcome, a component of the primary composite outcome, and a prespecified secondary endpoint in the trial.

Results: Overall, 2,141 participants were followed for a median of 2.1 years. A first fatal or nonfatal heart failure event occurred in 51 (4.7%) of 1,093 patients in the high-dose iron group and in 70 (6.7%) of 1,048 patients in the low-dose group (HR: 0.66; 95% CI: 0.46–0.94; P = 0.023). There was a total of 63 heart failure events (including first and recurrent events) in the high-dose iron group and 98 in the low-dose group, giving a rate ratio of 0.59 (95% CI: 0.40–0.87; P = 0.0084). Most patients presented with pulmonary edema and were mainly treated by mechanical removal of fluid. History of heart failure and diabetes were independent predictors of a heart failure event.

Conclusions: Compared with a lower-dose regimen, high-dose intravenous iron decreased the occurrence of first and recurrent heart failure events in patients undergoing hemodialysis, with large relative and absolute risk reductions. (UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients; 2013-002267-25).


© 2021 Published by Elsevier on behalf of the American College of Cardiology Foundation.

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