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Considerations for Clinical Trials Targeting the Myocardial Interstitium.
- Source :
-
JACC. Cardiovascular imaging [JACC Cardiovasc Imaging] 2019 Nov; Vol. 12 (11 Pt 2), pp. 2319-2331. Date of Electronic Publication: 2019 Aug 14. - Publication Year :
- 2019
-
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.<br /> (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Cardiomyopathies pathology
Cardiomyopathies physiopathology
Endpoint Determination
Extracellular Space
Fibrosis
Humans
Patient Selection
Sample Size
Time Factors
Treatment Outcome
Ventricular Remodeling
Cardiomyopathies therapy
Clinical Trials as Topic methods
Myocardium pathology
Research Design
Subjects
Details
- Language :
- English
- ISSN :
- 1876-7591
- Volume :
- 12
- Issue :
- 11 Pt 2
- Database :
- MEDLINE
- Journal :
- JACC. Cardiovascular imaging
- Publication Type :
- Academic Journal
- Accession number :
- 31422145
- Full Text :
- https://doi.org/10.1016/j.jcmg.2019.03.034