Hypertension Clinical Trial
— BR-102Official title:
Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
NCT number | NCT02596165 |
Other study ID # | EKNZ 2015-327 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | October 2016 |
Verified date | November 2020 |
Source | University of Basel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Basel | Kantonsspital Liestal |
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 |
Status | Clinical Trial | Phase | |
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Terminated |
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