Aortic Stiffness in Patients With Genetic Aortopathies

Rare Diseases Clinical Trial

— PULSEWAVE  

Official title:

Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715203
• Other study ID #: Pulse Wave
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Alessandro Pini, MD
• Phone: +390252774705
• Email: alessandro.pini[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to study arterial stiffness in patients with ascending aortic aneurysms, either syndromic or non syndromic. The main questions it aims to answer are: - Stratification of aortic risk based on Pulse Wave Velocity; - Compare measurements with morphological and hemodynamic features of the ascending thoracic aorta. Participants will be asked to undergo non invasive evaluation of blood pressure and arterial pulse wave velocity.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2024
• Est. primary completion date: February 2024
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stiffness
• Rare Diseases

Intervention

Device:
• Pulsotonometry
Evaluation of arterial stiffness

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato	Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?2 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	18 months