Ambulatory blood pressure monitoring in clinical trials.

Ambulatory blood pressure monitoring is increasingly used in clinical trials. The preliminary threshold values proposed for diagnosing hypertension and adjusting treatment based on ambulatory monitoring cannot yet be widely recommended because they have not been validated in prospective studies. The trough-to-peak or surface ratios may be useful instruments for assessing the duration of action of antihypertensive drugs. Trials with ambulatory monitoring just as clinical experiments based on conventional sphygmomanometry need to be properly controlled, because ambulatory blood pressure measurement is not completely devoid of a placebo effect. Ambulatory compared with conventional blood pressure measurements are characterized by higher reproducibility which makes it possible to reduce sample size in cross-over but not in parallel group trials. Finally, ambulatory monitors used in clinical research should have successfully passed one of the standardized validation protocols.