Aortic StiffnessBR-102NCT02596165
Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
A study testing Pulse wave analysis measurement with Schiller BR-102 Plus PWA device in people with Aortic Stiffness and Hypertension, run by University of Basel.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Stiffness, Hypertension
- What is being tested?
- Pulse wave analysis measurement with Schiller BR-102 Plus PWA device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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).
Read the 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.
- Conditions
- Aortic Stiffness, Hypertension
- Being tested
- Pulse wave analysis measurement with Schiller BR-102 Plus PWA device
- Keywords
- validation, pulse wave analysis, blood pressure monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse wave analysis measurement with Schiller BR-102 Plus PWA deviceDevice
Measurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Pulse wave analysis measurement with Schiller BR-102 Plus PWA device |
What is being measured
The primary outcome is the main question the study is designed to answer.
central blood pressure
Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device
Measured: 1 day
central arterial stiffness
Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device
Measured: 1 day
Secondary outcomes (1)
peripheral blood pressure
Measurement peripheral blood pressure with the Schiller BR-102 Plus PWA device
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionOct 2016
Why it stopped: Stopp because of FDA concrns regarding recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Liestal
- Responsible party
- Principal investigator, Arno Schmidt-Trucksäss, University of Basel
- Investigators
- Arno Schmidt-Trucksäss, MD, MA, Principal investigator, Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel, Basel, Switzerland, 4052
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596165
- Sponsor's protocol ID
- EKNZ 2015-327
- Acronym
- BR-102
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2015
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
- ClinicalTrials.gov ID
- NCT02596165
- Acronym / sponsor ID
- BR-102 / EKNZ 2015-327
- Conditions
- Aortic Stiffness, Hypertension
- Keywords
- validation, pulse wave analysis, blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopp because of FDA concrns regarding recruitment.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- Kantonsspital Liestal
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse wave analysis measurement | Experimental | Device: Pulse wave analysis measurement with Schiller BR-102 Plus PWA deviceMeasurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse wave analysis measurement with Schiller BR-102 Plus PWA deviceMeasurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device | Device | Pulse wave analysis measurement |
Primary outcome
central blood pressure
Time frame: 1 day
Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device
central arterial stiffness
Time frame: 1 day
Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device
1 secondary outcome
peripheral blood pressure
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Stopp because of FDA concrns regarding recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arno Schmidt-Trucksäss, MD, MA principal investigator
Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel, Basel, Switzerland, 4052
Questions about this trial
What is this clinical trial studying?
A study testing Pulse wave analysis measurement with Schiller BR-102 Plus PWA device in people with Aortic Stiffness and Hypertension, run by University of Basel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Stopp because of FDA concrns regarding recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central blood pressure (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.