Interleukin-1 blockade in heart failure with preserved ejection fraction: rationale and design of the Diastolic Heart Failure Anakinra Response Trial 2 (D-HART2)

Benjamin W. Van Tassell, Leo F. Buckley, Salvatore Carbone, Cory R. Trankle, Justin M. Canada, Dave L. Dixon, Nayef Abouzaki, Claudia Oddi-Erdle, Giuseppe Biondi-Zoccai, Ross Arena, Antonio Abbate

Research output: Contribution to journalArticlepeer-review

Abstract

Heart failure with preserved ejection fraction (HFpEF) now accounts for the majority of confirmed HF cases in the United States. However, there are no highly effective evidence-based treatments currently available for these patients. Inflammation correlates positively with adverse outcomes in HF patients. Interleukin (IL)-1, a prototypical inflammatory cytokine, has been implicated as a driver of diastolic dysfunction in preclinical animal models and a pilot clinical trial. The Diastolic Heart Failure Anakinra Response Trial 2 (D-HART2) is a phase 2, 2:1 randomized, double-blind, placebo-controlled clinical trial that will test the hypothesis that IL-1 blockade with anakinra (recombinant human IL-1 receptor antagonist) improves (1) cardiorespiratory fitness, (2) objective evidence of diastolic dysfunction, and (3) elevated inflammation in patients with HFpEF (http://www.ClinicalTrials.gov NCT02173548). The co–primary endpoints will be placebo-corrected interval changes in peak oxygen consumption and ventilatory efficiency at week 12. In addition, secondary and exploratory analyses will investigate the effects of IL-1 blockade on cardiac structure and function, systemic inflammation, endothelial function, quality of life, body composition, nutritional status, and clinical outcomes. The D-HART2 clinical trial will add to the growing body of evidence on the role of inflammation in cardiovascular disease, specifically focusing on patients with HFpEF.

Original languageEnglish
Pages (from-to)626-632
Number of pages7
JournalClinical Cardiology
Volume40
Issue number9
DOIs
Publication statusPublished - Sep 1 2017

Keywords

  • clinical trial study design
  • Heart Failure
  • Interleukin-1

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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