Right Ventricular Metrics as End Points in Clinical Trials

Importance: 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. Observations: 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. Conclusions and Relevance: 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.

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Publication Details

Journal
JAMA Cardiology
Published
2026-06-24
DOI
https://doi.org/10.1001/jamacardio.2026.2053
Primary Topic
Pulmonary Hypertension Research and Treatments
Type
article
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article

Right Ventricular Metrics as End Points in Clinical Trials

D Muraru, Елена Суркова, H T Kempton, S L Rosenkranz et al.
JAMA Cardiology
Pulmonary Hypertension Research and Treatments
article

Right Ventricular Metrics as End Points in Clinical Trials

D Muraru, Елена Суркова, H T Kempton, S L Rosenkranz, João A.C. Lima, B Borlaug, Martin Leon, Béla Merkely, Bálint Lakatos, Daniel Burkhoff, Jörg Hausleiter, Alex Pui-Wai Lee, Rebecca T. Hahn, Attila Kovács, JoAnn Lindenfeld
article en

Abstract

Importance: 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. Observations: 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. Conclusions and Relevance: 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.

JAMA Cardiology
Semmelweis University (HU), Mayo Clinic (US), Johns Hopkins University (US), Chinese University of Hong Kong (HK), University of Cologne (DE), Guy's and St Thomas' NHS Foundation Trust (GB), Columbia University Irving Medical Center (US), Johns Hopkins Medicine (US), Harefield Hospital (GB), LMU Klinikum (DE), IRCCS Istituto Auxologico Italiano (IT), AstraZeneca (Poland) (PL), Cardiovascular Research Foundation (US), Istituti di Ricovero e Cura a Carattere Scientifico (IT), University Hospital Cologne (DE), Imperial College London (GB), University of Milano-Bicocca (IT), Ludwig-Maximilians-Universität München (DE), Vanderbilt University Medical Center (US)
Industry, innovation and infrastructure
Openalex Percentile: Top 7%
Pulmonary Hypertension Research and Treatments
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