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

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

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
Journal	JACC: Cardiovascular Imaging
Early online date	14 Aug 2019
DOIs	https://doi.org/10.1016/j.jcmg.2019.03.034
Publication status	E-pub ahead of print - 14 Aug 2019

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title = "Considerations for Clinical Trials Targeting the Myocardial Interstitium",

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

AU - Selvanayagam, Joseph B

AU - Dweck, Marc R

AU - Miller, Christopher A

PY - 2019/8/14

Y1 - 2019/8/14

N2 - 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.

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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DO - 10.1016/j.jcmg.2019.03.034

M3 - Review article

C2 - 31422145

SN - 1936-878X

JO - JACC: Cardiovascular Imaging

JF - JACC: Cardiovascular Imaging

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Considerations for Clinical Trials Targeting the Myocardial Interstitium

Abstract

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