Within-Session Blood Pressure Variability in Clinical Trials

This white paper discusses within-session blood pressure variability (BPV) in clinical trials, authored by Luc Dekie, Ph.D., Jeff Heilbraun, M.S., Vickas Patel, M.D., Ph.D., and Todd Rudo, M.D. The document outlines the classification of BPV based on measurement frequency and methods, emphasizing the importance of accurate blood pressure measurement techniques in clinical settings. It details the variability observed in studies using both oscillometric and auscultatory methods, highlighting the lack of universally accepted guidelines for measuring BP in clinical trials. The paper presents data from various studies conducted at Clario, showing significant differences in systolic blood pressure (SBP) across consecutive measurements in both hypertensive and normotensive patients. Additionally, it reviews literature on BPV, noting that intrinsic and extrinsic factors contribute to variability. The findings underscore the need for standardized measurement practices to enhance the reliability of blood pressure assessments in clinical research.