TY - JOUR
T1 - Considerations for Clinical Trials Targeting the Myocardial Interstitium
AU - Lewis, Gavin A.
AU - Dodd, Susanna
AU - Naish, Josephine H.
AU - Selvanayagam, Joseph B.
AU - Dweck, Marc R.
AU - Miller, Christopher A.
PY - 2019/11
Y1 - 2019/11
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.
KW - cardiovascular magnetic resonance
KW - clinical trials
KW - myocardial fibrosis
KW - myocardial interstitium
UR - http://www.scopus.com/inward/record.url?scp=85073972260&partnerID=8YFLogxK
U2 - 10.1016/j.jcmg.2019.03.034
DO - 10.1016/j.jcmg.2019.03.034
M3 - Review article
C2 - 31422145
AN - SCOPUS:85073972260
VL - 12
SP - 2319
EP - 2331
JO - JACC: Cardiovascular Imaging
JF - JACC: Cardiovascular Imaging
SN - 1936-878X
IS - 11 Pt 2
ER -