NCT03446430

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 21, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
Last Updated

September 3, 2025

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

February 19, 2018

Last Update Submit

September 1, 2025

Conditions

Keywords

arterial stiffnesspulse wave velocitylaser Doppler vibrometry

Outcome Measures

Primary Outcomes (1)

  • carotid-femoral PWV measured by LDV

    day 1

Secondary Outcomes (4)

  • carotid PWV measured by LDV

    day 1

  • chest-carotid PWV measured by LDV

    day 1

  • carotid-femoral PWV measured by applanation tonometry

    day 1

  • carotid PWV measured by Echotracking

    day 1

Study Arms (1)

Hypertensives

EXPERIMENTAL

PWV measurement by LDV

Device: PWV measurement by LDV

Interventions

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

Hypertensives

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Européen Georges Pompidou / Service de Pharmacologie

Paris, 75015, France

Location

Related Publications (2)

  • Parker MA. Case of localized recombination in 23S rRNA genes from divergent bradyrhizobium lineages associated with neotropical legumes. Appl Environ Microbiol. 2001 May;67(5):2076-82. doi: 10.1128/AEM.67.5.2076-2082.2001.

    PMID: 11319084BACKGROUND
  • 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Pierre Boutouyrie, MD, PhD

    Pharmacology Department - Hopital Européen Georges Pompidou - Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 26, 2018

Study Start

June 21, 2018

Primary Completion

December 4, 2018

Study Completion

December 4, 2018

Last Updated

September 3, 2025

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations