Considerations for Clinical Trials Targeting the Myocardial Interstitium

Gavin A. Lewis, Susanna Dodd, Josephine H. Naish, Joseph B. Selvanayagam, Marc R. Dweck, Christopher A. Miller

Research output: Contribution to journalReview articlepeer-review

2 Citations (Scopus)

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 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 multicenter trials, stratifying trial recruitment according to the interstitium, and approaches to enrich recruitment, using examples of ongoing clinical trials.

Original languageEnglish
Pages (from-to)2319-2331
Number of pages13
JournalJACC: Cardiovascular Imaging
Volume12
Issue number11 Pt 2
DOIs
Publication statusPublished - Nov 2019

Keywords

  • cardiovascular magnetic resonance
  • clinical trials
  • myocardial fibrosis
  • myocardial interstitium

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