¹Medifacts, Ltd, Rockville, MD, USA

Abstract

The purpose of the presentation is to review and discuss present issues in the collection and analysis of 24 hour Ambulatory Blood Pressure Monitoring (ABPM). The focus is to standardize the general format for using ABPM in clinical trials.

ABPM has become a recognized means of evaluating the safety and efficacy of medications which may effect blood pressure response. Areas of research have included the fields of hypertension CNS, women's health and psychological/behavioral research.

Points of discussion will focus on:

1. A) A review of technology, auscultatory, oscillometry and combined devices with ECG

2. B) The use of the Mean Daytime Diastolic BP (MDDBP) vs the Mean 24 Diastolic BP (M24DBP) as an inclusion criteria for hypertension trials.

3. C) Defining Daytime and Nightime evaluation parameters including a look at the issue of Dippers vs non-dippers as well as the Siesta effect. This will be reviewed on global perspect. Attendees will walk away with a greater understanding of how to best incorporate ABPM technology into their trials as well as how best to review the data. There is a difference between using ABPM in clinical practice versus the incorporation of ABPM in a clinical trials program. There are a number of different models, our goal is to help review and clarify study design aspects of ABPM within clinical research.