Blood PressureMULTI-PWANCT05790642
Comparison of Different Non-invasive Methods to Assess Pulse Wave Analysis
An observational study of Blood Pressure and Arterial Stiffness, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The primary goal of the study is to compare different methods for pulse wave measurement and analysis which are cuffless and contactless. The novel measurement tools will be compared to cuff-based reference methods. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Arterial Stiffness, Arrythmia
- What is being tested?
- Pulse wave measurement and analysis
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 1 siteGermany
- Study dates
- 10 May 2023to 1 Sep 2024
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: general population
Who may be able to join
- older than 18 years
- male or female sex
- signed informed consent.
Who cannot join
- acute sickness which influences hemodynamic parameters
- arm circumference is below or above the limits for the blood pressure of the reference method (i.e. below 20 or above 40 cm)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Cardiovascular examination center of the University Medicine Greifswald
Greifswald, 17489
Martin Bahls, Ph.D., +49 3834 8680500, martin.bahls@uni-greifswald.de
About this study
Official title: Vergleich Verschiedener Nicht-invasiver Verfahren Zur Pulswellenanalyse
The primary goal of the study is to compare different methods for pulse wave measurement and analysis which are cuffless and contactless. The novel measurement tools will be compared to cuff-based reference methods.
- Conditions
- Blood Pressure, Arterial Stiffness, Arrythmia
- Being tested
- Pulse wave measurement and analysis
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse wave measurement and analysisDevice
Different contact-less and cuff-less pulse wave measurements will be used and compared to cuff-based reference method.
| Study group | Role | What they receive |
|---|---|---|
| Participants with sinus rhythm | Not described Receives: Device: Pulse wave measurement and analysis | |
| Participants with atrial fibrillation | Not described Receives: Device: Pulse wave measurement and analysis | |
| Participants with extra systoles | Not described Receives: Device: Pulse wave measurement and analysis | |
| Participants with heart failure with reduced ejection fraction | Not described Receives: Device: Pulse wave measurement and analysis | |
| Participants with mildly reduced or preserved ejection fraction | Not described Receives: Device: Pulse wave measurement and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure
Cuffless and contactless methods will be used to measure and analyze pulse wave velocity to estimate systolic and diastolic blood pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start10 May 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790642
- Sponsor's protocol ID
- 202103Multi-PWA
- Acronym
- MULTI-PWA
- Status last verified
- May 2023
- First submitted
- 17 Mar 2023
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vergleich Verschiedener Nicht-invasiver Verfahren Zur Pulswellenanalyse
- ClinicalTrials.gov ID
- NCT05790642
- Acronym / sponsor ID
- MULTI-PWA / 202103Multi-PWA
- Conditions
- Blood Pressure, Arterial Stiffness, Arrythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 30 Mar 2023 (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.
The primary goal of the study is to compare different methods for pulse wave measurement and analysis which are cuffless and contactless. The novel measurement tools will be compared to cuff-based reference methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Participants with sinus rhythm | – | Device: Pulse wave measurement and analysis |
| Participants with atrial fibrillation | – | Device: Pulse wave measurement and analysis |
| Participants with extra systoles | – | Device: Pulse wave measurement and analysis |
| Participants with heart failure with reduced ejection fraction | – | Device: Pulse wave measurement and analysis |
| Participants with mildly reduced or preserved ejection fraction | – | Device: Pulse wave measurement and analysis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- general population
Key inclusion criteria (3 listed)
- older than 18 years
- male or female sex
- signed informed consent.
Key exclusion criteria (2 listed)
- acute sickness which influences hemodynamic parameters
- arm circumference is below or above the limits for the blood pressure of the reference method (i.e. below 20 or above 40 cm)
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 measurement and analysisDifferent contact-less and cuff-less pulse wave measurements will be used and compared to cuff-based reference method. | Device | Participants with atrial fibrillation, Participants with extra systoles, Participants with heart failure with reduced ejection fraction, Participants with mildly reduced or preserved ejection fraction, Participants with sinus rhythm |
Primary outcome
Systolic and diastolic blood pressure
Time frame: 3 months
Cuffless and contactless methods will be used to measure and analyze pulse wave velocity to estimate systolic and diastolic blood pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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.
Cardiovascular examination center of the University Medicine Greifswald
Greifswald, Germany
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 Blood Pressure and Arterial Stiffness, run by University Medicine Greifswald 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 3 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressure (time frame: 3 months). 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 10 May 2023.