Arterial HypertensionMEASURE-cBP2NCT03049709
Non-invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis
An observational study of Arterial Hypertension and Healthy Control, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
There is growing evidence that central blood pressure is a better predictor of hypertensive end-organ damage and cardiovascular outcome than routine brachial readings. The investigators aimed to evaluate the accuracy of a novel device for the non-invasive determination of central blood pressure based on automated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension, Healthy Control, Coronary Heart Disease
- How many people
- 119 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2015to 30 Oct 2017
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: in-patients and healthy controls (students, hospital staff)
Who may be able to join
- cardiovascular disease, diabetes mellitus or healthy control
Who cannot join
- inability to give informed consent
- hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Automated Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis - Comparison With Non-Invasive Reference Values
There is growing evidence that central blood pressure is a better predictor of hypertensive end-organ damage and cardiovascular outcome than routine brachial readings.
The investigators aimed to evaluate the accuracy of a novel device for the non-invasive determination of central blood pressure based on automated oscillometric radial pulse wave analysis.
- Keywords
- central blood pressure, measurement, oscillometric radial pulse wave analysis
- Medical subject headings
- Hypertension, Coronary Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cardiovascular disease | patients with cardiovascular disease, invasive and non-invasive determination of central blood pressure | |
| healthy controls | healthy controls, invasive and non-invasive determination of central blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement of systolic central blood pressure measurements
Measured: 15 minutes
agreement of diastolic central blood pressure measurements
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 May 2015
- Primary completion31 May 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
- Investigators
- Jens J Kaden, MD, Principal investigator, Universitätsmedizin MannheimJoachim Saur, MD, Principal investigator, Universitätsmedizin MannheimUrs Benck, MD, Principal investigator, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049709
- Sponsor's protocol ID
- VA_noninvasive
- Acronym
- MEASURE-cBP2
- Status last verified
- Dec 2017
- First submitted
- 6 Feb 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Automated Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis - Comparison With Non-Invasive Reference Values
- ClinicalTrials.gov ID
- NCT03049709
- Acronym / sponsor ID
- MEASURE-cBP2 / VA_noninvasive
- Keywords
- central blood pressure, measurement, oscillometric radial pulse wave analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 10 Feb 2017 (actual)
- 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.
There is growing evidence that central blood pressure is a better predictor of hypertensive end-organ damage and cardiovascular outcome than routine brachial readings.
The investigators aimed to evaluate the accuracy of a novel device for the non-invasive determination of central blood pressure based on automated oscillometric radial pulse wave analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiovascular disease | – | –patients with cardiovascular disease, invasive and non-invasive determination of central blood pressure |
| healthy controls | – | –healthy controls, invasive and non-invasive determination of central blood pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in-patients and healthy controls (students, hospital staff)
Key inclusion criteria (1 listed)
- cardiovascular disease, diabetes mellitus or healthy control
Key exclusion criteria (2 listed)
- inability to give informed consent
- hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
agreement of systolic central blood pressure measurements
Time frame: 15 minutes
agreement of diastolic central blood pressure measurements
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Jens J Kaden, MD principal investigator
Universitätsmedizin Mannheim
Joachim Saur, MD principal investigator
Universitätsmedizin Mannheim
Urs Benck, MD principal investigator
Universitätsmedizin Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension and Healthy Control, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
agreement of systolic central blood pressure measurements (time frame: 15 minutes). 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 27 Dec 2017.