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Aortic Stiffness in Patients With Genetic Aortopathies

Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05715203
Acronym
PULSEWAVE
Enrollment
250
Registered
2023-02-06
Start date
2023-02-15
Completion date
2025-12-31
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stiffness, Connective Tissue Defect, Rare Diseases

Keywords

arterial stiffness, Ascending aortic aneurysm, pulse wave velocity

Brief 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 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.

Interventions

DEVICEPulsotonometry

Evaluation of arterial stiffness

Sponsors

Istituto Auxologico Italiano
CollaboratorOTHER
IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Subjects with AAT, either syndromic or non syndromic; * Signed informed consent

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pulse Wave Velocity18 monthsStatistic 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

Countries

Italy

Contacts

Primary ContactAlessandro Pini, MD
alessandro.pini@grupposandonato.it+390252774705

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026