Centre for Human Drug Research, Leiden, The Netherlands.
Leiden University Medical Center, Leiden, The Netherlands.
Clin Physiol Funct Imaging. 2024 Jan;44(1):36-43. doi: 10.1111/cpf.12846. Epub 2023 Aug 7.
Limited data exist on heart rate stabilization in the domiciled nature of phase I clinical studies, particularly when frequent measurements of QT intervals are involved. The present analysis aimed to evaluate heart rate stability in the domiciled nature of, and stabilization after a short exercise.
Fifty-six healthy male subjects were included in this analysis. Data during a domiciled clinical setting and after a short exercise were analysed. Mean values of 30 s intervals of collected electrocardiographical data (PR, RR, QT and QTcF intervals) during a 10-min supine resting period in a domiciled nature or after walking up and down three stories (100 steps) were compared to baseline values using paired t-tests or compared to the intrasubject standard deviation.
Stable heart rates and stable QTcF intervals observed immediately upon assuming a supine position in the domiciled clinical setting. After the short exercise, PR interval and RR interval were significantly (p < 0.05) shorter for up to 120 s (mean value -9.8 ± 7.2 ms) and 30 s (-160 ± 165 ms, p < 0.05), respectively. QT and QTcF intervals were significantly (p < 0.05) shorter for up to 90 and 120 s postexercise, respectively. Both QT and QTcF intervals stabilized after 2 min, but QT interval remained prolonged while QTcF interval returned to baseline levels.
In a clinical setting, male volunteers do not require a waiting period for electrocardiographic parameter normalization. However, accurate measurement of these parameters following a short exercise necessitates a minimum 2-min resting interval.
关于 I 期临床研究的居家环境中心率稳定的数据有限，尤其是当涉及频繁测量 QT 间期时。本分析旨在评估居家环境中的心率稳定性以及短暂运动后的稳定性。
本分析纳入了 56 名健康男性志愿者。分析了居家环境中的数据和短暂运动后的情况。在居家环境中，通过比较 10 分钟仰卧休息期间收集的心电图数据（PR、RR、QT 和 QTcF 间期）的 30 秒间隔的平均值与基线值，使用配对 t 检验或与个体内标准差进行比较；在短时间运动后，通过比较运动后至 120 秒（平均差值-9.8±7.2 毫秒）和 30 秒（-160±165 毫秒，p<0.05）的 PR 间期和 RR 间期的平均值与基线值，使用配对 t 检验或与个体内标准差进行比较。
在居家临床环境中，志愿者立即采取仰卧位时，心率和 QTcF 间期稳定。短暂运动后，PR 间期和 RR 间期分别在运动后至 120 秒（平均差值-9.8±7.2 毫秒）和 30 秒（-160±165 毫秒，p<0.05）时显著缩短。QT 和 QTcF 间期分别在运动后至 90 和 120 秒时显著缩短。QT 和 QTcF 间期在 2 分钟后均稳定，但 QT 间期仍延长，而 QTcF 间期恢复至基线水平。
在临床环境中，男性志愿者不需要等待心电图参数正常化。然而，在短暂运动后准确测量这些参数需要至少 2 分钟的休息间隔。
