Pulse WaveVOPRABIONCT03140735
Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis
A study testing Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction in people with Pulse Wave and Aortic Stenosis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in its most severe form of progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulse Wave, Aortic Stenosis
- What is being tested?
- Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2017to 20 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age, without legal protection (guardianship or curatorship),
- Stable hemodynamic status.
- Affiliation to a social security scheme
Who cannot join
- Hemodynamically unstable patients: Systolic PA <10 cmHg, rapid peripheral pulse and spinning, mottling, obnubilation, oliguria, sweating, coma
- History of significant valvulopathy other than an aortic stenosis,
- Pregnancy.
- Patient under tutelage or curatelle or deprived of public right.
Trial locations and contacts
1 site in 1 country.
About this study
Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in its most severe form of progression. The purpose of this study is to find a link between arterial stiffness and degenerative aortic stenosis. If this link is established, arterial stiffness may become a medical therapeutic target in order to delay the evolution of the disease.
- Conditions
- Pulse Wave, Aortic Stenosis
- Being tested
- Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction, Control group without heart disease
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constrictionOther
Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
Control group without heart diseaseOther
Control group without heart disease
| Study group | Role | What they receive |
|---|---|---|
| Control group of 150 heart disease-free individuals | Other | Not described Receives: Other: Control group without heart disease |
| Patients with aortic sclerosis | Other | Not described Receives: Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction |
| Patients with moderate aortic stenting (RA) | Other | Not described Receives: Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction |
| Patients with Serious Aortic Retention | Other | Not described Receives: Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start3 Jul 2017
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse WaveStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140735
- Sponsor's protocol ID
- PI2016_843_0035
- Acronym
- VOPRABIO
- Status last verified
- Jul 2023
- First submitted
- 14 Apr 2017
- Last updated
- 20 Jul 2023
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03140735
- Acronym / sponsor ID
- VOPRABIO / PI2016_843_0035
- Conditions
- Pulse Wave, Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 4 May 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.
Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in its most severe form of progression. The purpose of this study is to find a link between arterial stiffness and degenerative aortic stenosis. If this link is established, arterial stiffness may become a medical therapeutic target in order to delay the evolution of the disease.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group of 150 heart disease-free individuals | Other | Other: Control group without heart disease |
| Patients with aortic sclerosis | Other | Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction |
| Patients with moderate aortic stenting (RA) | Other | Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction |
| Patients with Serious Aortic Retention | Other | Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age, without legal protection (guardianship or curatorship),
- Stable hemodynamic status.
- Affiliation to a social security scheme
Key exclusion criteria (4 listed)
- Hemodynamically unstable patients: Systolic PA <10 cmHg, rapid peripheral pulse and spinning, mottling, obnubilation, oliguria, sweating, coma
- History of significant valvulopathy other than an aortic stenosis,
- Pregnancy.
- Patient under tutelage or curatelle or deprived of public right.
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 |
|---|---|---|
| Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constrictionStudy the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction | Other | Patients with Serious Aortic Retention, Patients with aortic sclerosis, Patients with moderate aortic stenting (RA) |
| Control group without heart diseaseControl group without heart disease | Other | Control group of 150 heart disease-free individuals |
Primary outcome
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
Time frame: 10 years
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction in people with Pulse Wave and Aortic Stenosis, run by Centre Hospitalier Universitaire, Amiens 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 20 Jul 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities (time frame: 10 years). 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 20 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.