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

NCT02596165 | Terminated

• 1 other identifier: EKNZ 2015-327
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Aortic Stiffness; Hypertension

Keywords

validation; pulse wave analysis; blood pressure monitoring

Outcome Measures

Primary Outcomes (2)

• central blood pressure

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

  1 day

• central arterial stiffness

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

  1 day

Secondary Outcomes (1)

• peripheral blood pressure

  1 day

Study Arms (1)

Pulse wave analysis measurement

EXPERIMENTAL

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

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

Interventions

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

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

Pulse wave analysis measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Basel: lead
• Kantonsspital Liestal: collaborator

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arno Schmidt-Trucksäss, MD, MA

  Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel, Basel, Switzerland, 4052

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Arno Schmidt-Trucksäss

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 4, 2015
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 17, 2020

Record last verified: 2020-11