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HypertensionCARDIS-PWVNCT03446430

Validation of Laser Doppler Vibrometer (LDV) for Measurement of Arterial Stiffness in Hypertensive Patients

A study testing PWV measurement by LDV in people with Hypertension, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim is to compare a new technique for assessing local and regional arterial stiffness: the Laser Doppler Vibrometry with the reference techniques, the applanation tonometry and echotracking. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hypertension
What is being tested?
PWV measurement by LDV
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteFrance
Study dates
21 Jun 2018to 4 Dec 2018
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with grade I-III essential arterial hypertension, recently diagnosed, well controlled or insufficiently equilibrated under stable antihypertensive treatment for their HTA

Who cannot join

  • Severe pathologies interfering with HTA or not allowing measurement by the techniques of interest, including skin diseases impeding the applanation tonometry
  • Allergies to ultrasound gel or to adhesive film

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hopital Européen Georges Pompidou / Service de Pharmacologie

    Paris, 75015

Other trials in France

About this study

The aim is to compare a new technique for assessing local and regional arterial stiffness: the Laser Doppler Vibrometry with the reference techniques, the applanation tonometry and echotracking.

Read the detailed description

Cardiovascular (CV) diseases and their risk factors are the major contributors to global morbidity and mortality. CV diseases are responsible for over 17.3 million deaths per year worldwide, representing 30% of all global deaths. The measurement of arterial stiffness during the medical investigation of a hypertensive subject is essential to estimate the overall CV risk. The European Society of Hypertension (ESH) and the European Society of Cardiology (ESC) working group recommend its use for CV risk assessment. Indeed, arterial stiffness is currently the subject of a scientific consensus due to the large number of pathophysiological, epidemiological and pharmacological studies demonstrating that it integrates the duration and the level of exposure of the patient to known and identified CV risk factors (hypertension, tobacco, diabetes...) as well as those still discussed or more difficult to quantify (low birth weight, inflammation, infection, genetics...).

Arterial stiffness can be assessed in a number of ways, but the non-invasive measurement of the carotid-femoral pulse wave velocity (cfPWV) by applanation tonometry is regarded as the current gold standard because it corresponds to the aortic stiffness and it has been widely validated in epidemiological studies. However, the routine measurement of PWV by applanation tonometry is technically demanding and uncomfortable for the patient because the sensors can be attached around the neck or involve a palpation of the groin. The more advanced devices for PWV assessment are bulky, require trained operators due to the complexity of the procedure, and are relatively expensive. Therefore, none of the devices available for measurement of PWV are suitable for use in primary care. Measurement of arterial stiffness at primary care would allow large population screening for CV risks and thus enable more accurate CV risk prediction to better target preventive therapy among those individuals considered to be at low or moderate risk according to current guidelines. However, the tools and devices available today do not allow for mobile, low-cost, reliable, fast and non- or minimally-invasive point-of-care screening for measurement of arterial stiffness.

PWV measurement by laser Doppler vibrometry, contactless, is more comfortable, acceptable and could thus be a substitute for applanation tonometry.

A laser Doppler vibrometer (LDV) is an instrument that is used to make non-contact vibration measurements of a surface. The laser beam from the LDV is directed at the surface of interest (in our case the skin covering the artery or the heart), and the vibration amplitude and frequency are extracted from the Doppler shift of the reflected laser beam frequency due to the motion of the surface. Preliminary data suggest that LDV can lead to an improved screening and assessment of CV risk as a technique that makes it possible to measure aortic and local PWV. Indeed, Ghent University has successfully demonstrated that aortic PWV can be correctly measured with LDV. This method will greatly simplify procedures for measuring aortic stiffness if it is available in a compact form and adapted to clinical practice. This is the purpose of the CARDIS project, H2020 (http://www.cardis-h2020.eu/), which aims to develop a compact device for measuring local and segmental arterial stiffness without contact to the skin thanks to the LDV technique. The objective of this study is to compare the CARDIS LDV prototype with the reference techniques, carotid-femoral and local carotid PWV.

Conditions
Hypertension
Being tested
PWV measurement by LDV
Keywords
arterial stiffness, pulse wave velocity, laser Doppler vibrometry
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PWV measurement by LDVDevice

    PWV measurement by LDV : carotid-femoral, carotid and chest-carotid

Study groups in NCT03446430
Study groupRoleWhat they receive
HypertensivesExperimentalPWV measurement by LDV
Receives: Device: PWV measurement by LDV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. carotid-femoral PWV measured by LDV

    Measured: day 1

Secondary outcomes (4)
  1. carotid PWV measured by LDV

    Measured: day 1

  2. chest-carotid PWV measured by LDV

    Measured: day 1

  3. carotid-femoral PWV measured by applanation tonometry

    Measured: day 1

  4. carotid PWV measured by Echotracking

    Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2018
  2. Study start21 Jun 2018
  3. Primary completion4 Dec 2018
  4. Study completion4 Dec 2018

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03446430
Sponsor's protocol ID
C17-43
Acronym
CARDIS-PWV
Status last verified
Sep 2019
First submitted
19 Feb 2018
Last updated
3 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Badhwar S, Marais L, Khettab H, Poli F, Li Y, Segers P, Aasmul S, de Melis M, Baets R, Greenwald S, Bruno RM, Boutouyrie P. Clinical Validation of Carotid-Femoral Pulse Wave Velocity Measurement Using a Multi-Beam Laser Vibrometer: The CARDIS Study. Hypertension. 2024 Sep;81(9):1986-1995. doi: 10.1161/HYPERTENSIONAHA.124.22729. Epub 2024 Jun 27.

    PubMed 38934112

Questions about this trial

What is this clinical trial studying?

A study testing PWV measurement by LDV in people with Hypertension, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

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 3 Sep 2025. 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 France. 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?

carotid-femoral PWV measured by LDV (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03446430, which also lists 1 linked publication.

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 3 Sep 2025.

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