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Right Ventricular Metrics as End Points in Clinical Trials: A Review
Elena Surkova1,2,3, Bálint Lakatos4, Hannah Kempton5
1Translational Science and Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
Right ventricular (RV) parameters are crucial for cardiovascular clinical trials but are underused. Standardizing RV metrics and using new tools can improve trial efficiency and patient outcomes.
Area of Science:
- Cardiovascular Medicine
- Clinical Trials
- Medical Imaging
Background:
- Right ventricular (RV) structure and function are vital in cardiovascular diseases.
- RV parameters are underutilized and inconsistently applied in clinical trials.
- Current methods lack standardization and validation for long-term outcomes.
Purpose of the Study:
- To explore the role of RV-focused imaging and hemodynamic parameters in clinical trials.
- To propose a framework for developing, validating, and implementing RV end points.
- To enhance the efficiency and sensitivity of cardiovascular clinical trials.
Main Methods:
- Review of current and emerging RV-focused parameters from echocardiography, MRI, CT, and heart catheterization.
- Analysis of limitations including variability, data capture, and standardization.
- Consideration of emerging tools like AI and collaborative efforts.
Main Results:
- RV parameters show potential value across diverse conditions like heart failure and pulmonary hypertension.
- Inconsistent use and feasibility challenges hinder multicenter trial application.
- Lack of standardized protocols and validation limits linking short-term RV changes to clinical outcomes.
Conclusions:
- RV-specific end points promise enhanced trial sensitivity and mechanistic insight.
- Optimal end points balance clinical relevance, analytical validity, and operational feasibility.
- Standardization, validation, and collaboration are key for broader adoption and improved patient outcomes.
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