Considerations for clinical trials targeting the myocardial interstitium

Gavin Lewis, Susanna Dodd, Josephine Naish, Joseph Selvanayagam, Marc R Dweck, Christopher Miller

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Abstract

The myocardial interstitium has emerged as a potential therapeutic target, and as a biological entity to improve risk stratification and better guide existing interventions. Clinical trials focusing on the myocardial interstitium are required in order to establish causality and improve patient outcomes. This review will discuss issues around clinical trials targeting the myocardial interstitium, including antifibrotic therapies, efficacy outcome measurements, mechanistic outcome measurements and mediation analysis, sample size, trial duration, considerations for multicentre trials, stratifying trial recruitment according to the interstitium and approaches to enrich recruitment, using examples of ongoing clinical trials.
Original languageEnglish
JournalJACC: Cardiovascular Imaging
DOIs
Publication statusPublished - 14 Aug 2019

Keywords

  • Myocardial interstitium
  • Myocardial fibrosis
  • Cardiovascular magnetic resonance
  • Clinical trials

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