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

Hypertension Clinical Trial

— BR-102  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02596165
• Other study ID #: EKNZ 2015-327
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2020
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stiffness
• Hypertension

Intervention

Device:
• Pulse wave analysis measurement with Schiller BR-102 Plus PWA device
Measurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Basel	Kantonsspital Liestal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central blood pressure	Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device	1 day
Primary	central arterial stiffness	Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device	1 day
Secondary	peripheral blood pressure	Measurement peripheral blood pressure with the Schiller BR-102 Plus PWA device	1 day