Rare DiseasesPULSEWAVENCT05715203
Aortic Stiffness in Patients With Genetic Aortopathies
An observational study of Rare Diseases and Aortic Stiffness, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The goal of this observational study is to study arterial stiffness in patients with thoracic ascending aortic aneurysms (TAA), either syndromic or non-syndromic. The main questions it aims to answer are: Stratification of aortic risk based on arterial stiffness; Compare measurements with morphological and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rare Diseases, Aortic Stiffness, Connective Tissue Defect
- What is being tested?
- Pulsotonometry
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2023to 31 Dec 2025
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with ascending aortic aneurysms currently in follow.up at Cardiovascular Gentic Centre, IRCCS Policlinico San Donato.
Who may be able to join
- Subjects with AAT, either syndromic or non syndromic;
- Signed informed consent
Who cannot join
- Patients with early menopause and/or osteoporosis, rheumatic heart disease and active malignant tumours;
- Patients with acute and chronic inflammatory conditions such as: chronic liver disease, chronic renal insufficiency and diseases affecting the thyroid system;
- Seropositivity to HIV, HCV, HBsAg and SARS-CoV-2;
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, 20097
Alessandro Pini, MD, +390252774705, alessandro.pini@grupposandonato.it
About this study
Official title: Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis
The goal of this observational study is to study arterial stiffness in patients with thoracic ascending aortic aneurysms (TAA), either syndromic or non-syndromic. The main questions it aims to answer are:
- Stratification of aortic risk based on arterial stiffness; Compare measurements with morphological and haemodynamic features of the ascending thoracic aorta.
Participants will be asked to undergo non-invasive evaluation of blood pressure and arterial stiffness.
Read the detailed description
Recent studies have highlighted the role played by the aorta and the great arteries in the regulation of the blood pressure (BP) and peripheral blood flow. Similarly, the structural and functional alteration of the aortic wall having a genetic cause is highly associated with the onset of aneurysms, especially of the ascending aorta, for which it is essential to monitor the aortic stiffness, which is detectable through a non-invasive and non-radioactive method such as Pulse Wave Velocity (PWV). Despite literature studies correlating PWV in MFS, few evaluations of aortic stiffness in patients with syndromic TAA have been done and its potential correlations with other aneurysm markers.
- Conditions
- Rare Diseases, Aortic Stiffness, Connective Tissue Defect
- Being tested
- Pulsotonometry
- Keywords
- arterial stiffness, Ascending aortic aneurysm, pulse wave velocity
- Medical subject headings
- Rare Diseases, Aneurysm, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulsotonometryDevice
Evaluation of arterial stiffness
| Study group | Role | What they receive |
|---|---|---|
| Syndromic TAA | Subjets with clinical or genetic diagnosis of syndromic thoracic aortic aneurysms Receives: Device: Pulsotonometry | |
| Non-syndromic TAA | Subjets without clinical or genetic diagnosis of syndromic thoracic aortic aneurysms Receives: Device: Pulsotonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity
Statistic analysis will be performed using the Statistical Package for Social Science (SPSS for Windows; v20.0; SPSS, Chicago, Illinois, USA). Continuous variables will be expressed as mean ± Standard Deviation, while qualitative variables will be expressed as a percentage. Qualitative data will be compared using Fisher's test or Pearson's χ2 test, when appropriate. Continuous variables by t-test or analysis of variance normalized for covariates. Continuous variables will be correlated by simple or multiple linear regression
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start15 Feb 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare DiseasesStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe 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
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Auxologico Italiano
- Responsible party
- Principal investigator, Alessandro Pini, IRCCS Policlinico S. Donato
- Investigators
- Alessandro Pini, Principal investigator, Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715203
- Sponsor's protocol ID
- Pulse Wave
- Acronym
- PULSEWAVE
- Status last verified
- Jul 2025
- First submitted
- 27 Jan 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis
- ClinicalTrials.gov ID
- NCT05715203
- Acronym / sponsor ID
- PULSEWAVE / Pulse Wave
- Conditions
- Rare Diseases, Aortic Stiffness, Connective Tissue Defect
- Keywords
- arterial stiffness, Ascending aortic aneurysm, pulse wave velocity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Collaborators
- Istituto Auxologico Italiano
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Feb 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 goal of this observational study is to study arterial stiffness in patients with thoracic ascending aortic aneurysms (TAA), either syndromic or non-syndromic. The main questions it aims to answer are:
- Stratification of aortic risk based on arterial stiffness; Compare measurements with morphological and haemodynamic features of the ascending thoracic aorta.
Participants will be asked to undergo non-invasive evaluation of blood pressure and arterial stiffness.
Detailed description
Recent studies have highlighted the role played by the aorta and the great arteries in the regulation of the blood pressure (BP) and peripheral blood flow. Similarly, the structural and functional alteration of the aortic wall having a genetic cause is highly associated with the onset of aneurysms, especially of the ascending aorta, for which it is essential to monitor the aortic stiffness, which is detectable through a non-invasive and non-radioactive method such as Pulse Wave Velocity (PWV). Despite literature studies correlating PWV in MFS, few evaluations of aortic stiffness in patients with syndromic TAA have been done and its potential correlations with other aneurysm markers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syndromic TAA | – | Device: PulsotonometrySubjets with clinical or genetic diagnosis of syndromic thoracic aortic aneurysms |
| Non-syndromic TAA | – | Device: PulsotonometrySubjets without clinical or genetic diagnosis of syndromic thoracic aortic aneurysms |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ascending aortic aneurysms currently in follow.up at Cardiovascular Gentic Centre, IRCCS Policlinico San Donato.
Key inclusion criteria (2 listed)
- Subjects with AAT, either syndromic or non syndromic;
- Signed informed consent
Key exclusion criteria (4 listed)
- Patients with early menopause and/or osteoporosis, rheumatic heart disease and active malignant tumours;
- Patients with acute and chronic inflammatory conditions such as: chronic liver disease, chronic renal insufficiency and diseases affecting the thyroid system;
- Seropositivity to HIV, HCV, HBsAg and SARS-CoV-2;
- Pregnancy
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 |
|---|---|---|
| PulsotonometryEvaluation of arterial stiffness | Device | Non-syndromic TAA, Syndromic TAA |
Primary outcome
Pulse Wave Velocity
Time frame: 18 months
Statistic analysis will be performed using the Statistical Package for Social Science (SPSS for Windows; v20.0; SPSS, Chicago, Illinois, USA). Continuous variables will be expressed as mean ± Standard Deviation, while qualitative variables will be expressed as a percentage. Qualitative data will be compared using Fisher's test or Pearson's χ2 test, when appropriate. Continuous variables by t-test or analysis of variance normalized for covariates. Continuous variables will be correlated by simple or multiple linear regression
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 10 Sep 2025.
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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.
Alessandro Pini principal investigator
Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato
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 Rare Diseases and Aortic Stiffness, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 2 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: looking for participants now, as of the sponsor's last update on 10 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 Italy. 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 Alessandro Pini, MD (+390252774705, alessandro.pini@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave Velocity (time frame: 18 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 Sep 2025.