Right Ventricular Metrics as End Points in Clinical Trials: A Review.
Authors
Affiliations (16)
Affiliations (16)
- Translational Science and Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
- Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
- National Heart and Lung Institute, Imperial College, London, United Kingdom.
- Heart and Vascular Center, Semmelweis University, Budapest, Hungary.
- Medizinische Klinik und Poliklinik I, LMU Klinikum, LMU München, Munich, Germany.
- Li Ka Shing Institute of Health Sciences, the Chinese University of Hong Kong, Shat Tin, Hong Kong.
- Vanderbilt University Medical Center, Nashville, Tennessee.
- Division of Cardiology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
- Department of Cardiology-Internal Medicine III, Heart Center, University Hospital Cologne, Cologne, Germany.
- Cologne Cardiovascular Research Center, Heart Center, University Hospital Cologne, Cologne, Germany.
- Center for Molecular Medicine Cologne, Faculty of Medicine, University of Cologne, Cologne, Germany.
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.
- Cardiovascular Research Foundation, New York, New York.
- Department of Cardiology, Istituto Auxologico Italiano, IRCCS, Milan, Italy.
- Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
- Irving Medical Center, Columbia University, New York, New York.
Abstract
Clinical trials in cardiovascular medicine aim to deliver high-quality evidence with greater efficiency, including smaller sample sizes and shorter timelines. The selection of sensitive and reliable end points is central to this goal. Right ventricular (RV) structure and function play a critical role in many cardiovascular conditions; however, RV-specific parameters remain underused and inconsistently applied in interventional clinical trials. In this article, the current and emerging role of RV-focused imaging and hemodynamic parameters as end points in clinical trials are explored and a comprehensive framework for their development, validation, and broader implementation is proposed. Across multiple disease domains, RV-focused parameters derived from echocardiography, cardiac magnetic resonance imaging, computed tomography, and right-sided heart catheterization demonstrate potential value in assessing the therapeutic effects of new medicines or devices across a wide range of conditions including heart failure, cardiomyopathies, valve diseases, pulmonary hypertension, and congenital heart conditions. However, their use is inconsistent, and feasibility challenges are common, particularly in multicenter clinical trial settings. Key limitations include variability in imaging acquisition, incomplete data capture, lack of standardized protocols, and insufficient validation linking short-term RV changes to long-term clinical outcomes. Emerging tools such as artificial intelligence may improve reproducibility and efficiency, while collaborative, multidisciplinary efforts are essential for advancing end-point development. RV-specific end points hold substantial promise for enhancing the sensitivity and mechanistic insight of clinical trials but remain inadequately integrated into current practice. Optimal end-point selection requires balancing clinical relevance, analytical validity, and operational feasibility, with consideration of disease-specific pathophysiology and trial design. Standardization of acquisition, validation of clinically meaningful changes, and centralized data analysis are important next steps. Broader adoption of robust RV metrics supported by technological innovation and cross-sector collaboration has the potential to improve trial efficiency, accelerate therapeutic development, and ultimately enhance patient outcomes.