TY - JOUR
T1 - Considerations for clinical trials targeting the myocardial interstitium
AU - Lewis, Gavin
AU - Dodd, Susanna
AU - Naish, Josephine
AU - Selvanayagam, Joseph
AU - Dweck, Marc R
AU - Miller, Christopher
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 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.
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 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.
KW - Myocardial interstitium
KW - Myocardial fibrosis
KW - Cardiovascular magnetic resonance
KW - Clinical trials
U2 - 10.1016/j.jcmg.2019.03.034
DO - 10.1016/j.jcmg.2019.03.034
M3 - Article
SN - 1936-878X
JO - JACC: Cardiovascular Imaging
JF - JACC: Cardiovascular Imaging
ER -
