BARRON ASSOCIATES, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Summary Abstract Hypertension is a leading cause of excess cardiovascular morbidity and mortality and remains a signi cant national problem with approximately one third of all adults having high blood pressure BP BP monitoring has high diagnostic and prognostic value as an important marker of cardiovascular disease Static BP snapshots which are typically obtained via sphygmomanometry during doctorandapos s oce visits have documented reliability issues the causes of which include \white coatandquot hypertension and poor technique As a result electronic oscillometric devices that are worn on the upper arm and are designed for self blood pressure measurement SBPM have seen widespread adoption however these devices also su er from poor reliability as measurements are seldom performed according to the speci ed guidelines e g measurements taken with the patient seated arm cu maintained at heart level arm cu kept stationary and no talking or leg crossing Auscultatory or oscillometric cu based ambulatory BP monitors ABPMs that can be worn in home settings and provide regular automated measurements over h periods|and most importantly during sleep|have become the clinical standard reportedly providing more accurate and reliable results However these devices still require the patient to follow the same guidelines as SBPMs yield intermittent measurements only e g every min during the day every min at night and are found by many patients to be obtrusive and uncomfortable The proposed Cardiovascular Hemodynamics Processing System CHAMPS will be a reliable easy to use and comfortable i e non cu based continuous i e beat to beat ambulatory BP monitor cABPM that can operate around the clock even during activities of daily living ADL This new class of BP monitor will be an important addition to clinical practice accurately and unobtrusively assessing individuals with established or suspected hypertension even during movement and without uncomfortable cu in ations CHAMPS provides accurate BP estimates without restricting usersandapos mobility body postures or arm elevations In the proposed SBIR Phase I e ort Barron Associates seeks to demonstrate proof of concept for CHAMPS via rigorous evaluation of a new algorithm that obviates the need for repeated calibrations traditionally associated with pulse transit time PTT based systems CHAMPS beat to beat BP estimates may be used directly or averaged over arbitrary intervals e g to mimic conventional ABPMs In Phase I CHAMPS systolic diastolic and mean arterial BP estimates obtained during rest di erent postures and arm elevations and treadmill exercise will be compared directly with criterion BP measurements obtained using a clinical laboratory system speci cally designed for application in cardiac stress and exercise testing Comparisons between CHAMPS BP estimates and criterion measurements will be obtained in each participant during two min test periods separated by h to demonstrate the ability of CHAMPS to provide accurate BP estimates without recalibration CHAMPS will ful ll the need for an ergonomic accurate reliable and low cost cABPM for use in healthcare and clinical research Project Narrative The proposed CHAMPS technology will be very useful across all age ranges not only clinically but also in daily life and in research for cardiovascular disease prevention and management through early detection of cardiovascular risk e g high BP obesity \non dippersandquot |i e those whose BP does not fall by at night and cardiovascular events during exercise or exertion Two signi cant advantages of the proposed CHAMPS technology are that recalibration is not required over extended measurement periods and patients have freedom of movement not constrained by arm cu s pressure tubing and waist monitors that are intrusive interfering and conspicuous Continuous beat to beat measurement of systolic diastolic and mean arterial BP is important to avoid missing signi cant cardiovascular events and will enable telemonitoring of patientsandapos BP in home settings similar to present day ECG telemonitoring CHAMPS will be the only low cost non cu based wireless BP monitor on the market it will usher in the new era of cABPM and will enable the calculation of new measures for which there is strong clinical interest|e g BP variability BPV increases of which are associated with the development progression and severity of cardiac vascular and renal damage and with an increased risk of cardiovascular events and mortality|but which are not presently measurable in the home setting