Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics

University of Basel

Status: Terminated

Conditions: Hypertension; Aortic Stiffness

Treatments: Device: Pulse wave analysis measurement with Schiller BR-102 Plus PWA device

Study type: Interventional

Funder types: Other

Identifiers

NCT02596165

EKNZ 2015-327

Details and patient eligibility

About

The significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level. The purpose of this study is to evaluate the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland).

Full description

The proposed study is an open, monocentric cross-sectional research study for the evaluation of the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland). For that purpose measurement of the respective parameters in cardiovascular disease free individuals will be compared with validated devices and the agreement between the devices will be statistically analyzed. Central blood pressure and central arterial stiffness are clinically increasingly meaningful parameters of the cardiovascular system that allow improved, early cardiovascular risk stratification. The significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals free of clinically relevant cardiovascular diseases or diabetes based on medical history and physical examination.
• Heart rhythm: Sinus rhythm
• Blood pressure range: 10 to 12 subjects in each of the three systolic blood pressure (SBP) and three diastolic blood pressure (DBP) recruitment ranges (low, medium, high).

Exclusion criteria

• Cardiac arrhythmia (atrial fibrillation, frequent extrasystoles)
• Pacemaker-dependent
• Pregnancy after the 6th month of the pregnancy
• Body mass index (BMI)>30 kg/m2
• Known significant carotid or femoral artery stenosis
• Impalpable arterial pulse at site of measurement
• Age under 18 years.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Pulse wave analysis measurement

Experimental group

Description:

Measurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device

Treatment:

Device: Pulse wave analysis measurement with Schiller BR-102 Plus PWA device