Arterial StiffnessPPS3-2NCT06079424
Risk Markers of Arterial Aging. The Paris Prospective Study III-2
An observational study of Arterial Stiffness, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The main objectives of PPS3-2 are (i) to describe the dynamics of vascular aging and baroreflex sensitivity 12 to 16 years a part, (ii) to identify their determinants, and (iii) to quantify the subsequent risk of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness
- What is being tested?
- high-precision carotid echo-tracking
- How many people
- 7,500 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2025to Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women aged 60 to 95 years who are participants of the PPS3 study and have accepted to undergo a second physical examination and answer to health questionnaires in primary care health centre in Paris that is subsidized by the French Health Insurance System.
Who may be able to join
- Being enrolled in PPS3 and having signed an informed consent for PPS3-2
Who cannot join
- Institutionalized participants
- Participants under guardianship
- Participants under judicial safeguard measure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xavier Jouven, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Centre d'Investigation Précliniques
Paris, 75016
Nicolas Danchin, 0153673535, nicolas.danchin@egp.aphp.fr
Jean-Philippe Empana, jean-philippe.empana@inserm.fr
About this study
Official title: Risk Markers of Arterial Aging and Subsequent Risk of Cardiovascular Diseases and Beyond. The Paris Prospective Study III-2
The main objectives of PPS3-2 are (i) to describe the dynamics of vascular aging and baroreflex sensitivity 12 to 16 years a part, (ii) to identify their determinants, and (iii) to quantify the subsequent risk of cardiovascular diseases.
Read the detailed description
Since May 2008, PPS3 is being following the CVD morbidity of 10157 healthy volunteers aged 50-75 years at baseline. In PPS3-2, we plan to re-invite survivors and volunteers of PPS3 to undergo a second physical examination. In particular, they will undergo a second high-precision carotid echotracking to measure vascular aging parameters and baroreflex sensitivity, permitting to study their respective dynamics. They will also underwent for the first time ultra fast echo of the radial artery to measure vascular aging parameters of the medium-sized arteries. According to fundings, blood samples will be taken and stored at -80°C in the whole population or in a subsample.
- Conditions
- Arterial Stiffness
- Being tested
- high-precision carotid echo-tracking
- Keywords
- risk factors, cohort, cardiovascular diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-precision carotid echo-trackingOther
evaluation of vascular aging parameters and baroreflex sensitivity
| Study group | Role | What they receive |
|---|---|---|
| Level of vascular aging | community-based prospective longitudinal cohort Receives: Other: high-precision carotid echo-tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid diameter
high precision carotid echo tracking diameter in mm
Measured: by 2027
intima media thickness
high precision echo tracking intima media thickness of the common carotid artery in mm
Measured: by 2027
carotid plaques
high precision carotid echo tracking carotid plaques
Measured: by 2027
wall cross sectional area
high precision carotid echo tracking carotid wall cross sectional area, mm2
Measured: by 2027
distensibility coefficient
high precision carotid echo tracking distensibility coefficient in 10-3/kPa
Measured: by 2027
elastic modulus
high precision carotid echo tracking Young's elastic modulus, 10-3*kPa
Measured: by 2027
pulse wave velocity
high precision carotid echotracking pulse wave velocity, m/s
Measured: by 2027
carotid wall stress
high precision carotid echotracking circumferential wall stress in kPa
Measured: by 2027
stiffness
high precision carotid echotracking Beta stiffness index
Measured: by 2027
pulse pressure
high precision carotid echotracking pulse pressure in mmHg
Measured: by 2027
Secondary outcomes (10)
brachial artery diameter
ultra high frequency ultrasound radial artery diameter in mm
Measured: by 2027
thickness of the intima media of the radial artery
ultra high frequency ultrasound radial artery intima media thickness in mm
Measured: by 2027
arterial plaques
ultra high frequency ultrasound radial artery plaques
Measured: by 2027
wall cross sectional area of the radial artery
ultra high frequency ultrasound radial artery wall cross sectional area, mm2
Measured: by 2027
distensibility of the radial artery
ultra high frequency ultrasound radial artery distensibility coefficient in 10-3/kPa
Measured: by 2027
elastic modulus of the radial artery
ultra high frequency ultrasound radial artery Young's elastic modulus, 10-3*kPa
Measured: by 2027
pulse wave velocity of the radial artery
ultra high frequency ultrasound radial artery Pulse wave velocity, m/s
Measured: by 2027
stiffness index of the radial artery
ultra high frequency ultrasound radial artery Beta stiffness index
Measured: by 2027
wall stress of the radial artery
ultra high frequency ultrasound radial artery Circumferential wall stress, kPa
Measured: by 2027
pulse pressure of the radial artery
ultra high frequency ultrasound radial artery Pulse Pressure, mmHg
Measured: by 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start20 Jun 2025
- Primary completionMay 2031 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- 7,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Empana, MD, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079424
- Sponsor's protocol ID
- C21-67
- Acronym
- PPS3-2
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Markers of Arterial Aging and Subsequent Risk of Cardiovascular Diseases and Beyond. The Paris Prospective Study III-2
- ClinicalTrials.gov ID
- NCT06079424
- Acronym / sponsor ID
- PPS3-2 / C21-67
- Conditions
- Arterial Stiffness
- Keywords
- risk factors, cohort, cardiovascular diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 12 Oct 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 main objectives of PPS3-2 are (i) to describe the dynamics of vascular aging and baroreflex sensitivity 12 to 16 years a part, (ii) to identify their determinants, and (iii) to quantify the subsequent risk of cardiovascular diseases.
Detailed description
Since May 2008, PPS3 is being following the CVD morbidity of 10157 healthy volunteers aged 50-75 years at baseline. In PPS3-2, we plan to re-invite survivors and volunteers of PPS3 to undergo a second physical examination. In particular, they will undergo a second high-precision carotid echotracking to measure vascular aging parameters and baroreflex sensitivity, permitting to study their respective dynamics. They will also underwent for the first time ultra fast echo of the radial artery to measure vascular aging parameters of the medium-sized arteries. According to fundings, blood samples will be taken and stored at -80°C in the whole population or in a subsample.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Level of vascular aging | – | Other: high-precision carotid echo-trackingcommunity-based prospective longitudinal cohort |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women aged 60 to 95 years who are participants of the PPS3 study and have accepted to undergo a second physical examination and answer to health questionnaires in primary care health centre in Paris that is subsidized by the French Health Insurance System.
Key inclusion criteria (1 listed)
- Being enrolled in PPS3 and having signed an informed consent for PPS3-2
Key exclusion criteria (3 listed)
- Institutionalized participants
- Participants under guardianship
- Participants under judicial safeguard measure
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 |
|---|---|---|
| high-precision carotid echo-trackingevaluation of vascular aging parameters and baroreflex sensitivity | Other | Level of vascular aging |
Primary outcome
carotid diameter
Time frame: by 2027
high precision carotid echo tracking diameter in mm
intima media thickness
Time frame: by 2027
high precision echo tracking intima media thickness of the common carotid artery in mm
carotid plaques
Time frame: by 2027
high precision carotid echo tracking carotid plaques
wall cross sectional area
Time frame: by 2027
high precision carotid echo tracking carotid wall cross sectional area, mm2
distensibility coefficient
Time frame: by 2027
high precision carotid echo tracking distensibility coefficient in 10-3/kPa
elastic modulus
Time frame: by 2027
high precision carotid echo tracking Young's elastic modulus, 10-3*kPa
pulse wave velocity
Time frame: by 2027
high precision carotid echotracking pulse wave velocity, m/s
carotid wall stress
Time frame: by 2027
high precision carotid echotracking circumferential wall stress in kPa
stiffness
Time frame: by 2027
high precision carotid echotracking Beta stiffness index
pulse pressure
Time frame: by 2027
high precision carotid echotracking pulse pressure in mmHg
10 secondary outcomes
brachial artery diameter
Time frame: by 2027
thickness of the intima media of the radial artery
Time frame: by 2027
arterial plaques
Time frame: by 2027
wall cross sectional area of the radial artery
Time frame: by 2027
distensibility of the radial artery
Time frame: by 2027
elastic modulus of the radial artery
Time frame: by 2027
pulse wave velocity of the radial artery
Time frame: by 2027
stiffness index of the radial artery
Time frame: by 2027
wall stress of the radial artery
Time frame: by 2027
pulse pressure of the radial artery
Time frame: by 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Related trials for Arterial Stiffness
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Recruiting
Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults
Aging
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.
Xavier Jouven, MD, PhD contact
Jean-Philippe Empana, MD, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
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 Stiffness, 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 3 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Philippe Empana, MD, PhD (33153988020, jean-philippe.empana@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid diameter (time frame: by 2027). The study lists 10 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 Sep 2026.