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

doi:10.1016/j.jcmg.2019.03.034

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

College of Medicine and Public Health

Research output: Contribution to journal › Review article › peer-review

13 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 language	English
Pages (from-to)	2319-2331
Number of pages	13
Journal	JACC: Cardiovascular Imaging
Volume	12
Issue number	11 Pt 2
DOIs	https://doi.org/10.1016/j.jcmg.2019.03.034
Publication status	Published - Nov 2019

Keywords

cardiovascular magnetic resonance
clinical trials
myocardial fibrosis
myocardial interstitium

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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 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.",

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AU - Dodd, Susanna

AU - Naish, Josephine H.

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AU - Dweck, Marc R.

AU - Miller, Christopher A.

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AB - 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.

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KW - clinical trials

KW - myocardial fibrosis

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Considerations for Clinical Trials Targeting the Myocardial Interstitium

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