Clinical trial NCT02596165: Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
Official title: Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Stiffness
Hypertension
Keywords: validation
pulse wave analysis
blood pressure monitoring
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Kantonsspital Liestal
First posted: 2015-11-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: central blood pressure
timeFrame: 1 day
measure: central arterial stiffness
timeFrame: 1 day
Secondary outcomes:
measure: peripheral blood pressure
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel, Basel, Switzerland, 4052
name: Arno Schmidt-Trucksäss, MD, MA
role: PRINCIPAL_INVESTIGATOR
References: