Aortic Stiffness in Patients With Genetic Aortopathies (PULSEWAVE)

San Donato Group (GSD)

Status: Enrolling

Conditions: Aortic Stiffness; Connective Tissue Defect; Rare Diseases

Treatments: Device: Pulsotonometry

Study type: Observational

Funder types: Other

Identifiers

NCT05715203

Pulse Wave

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Syndromic TAA

Description:

Subjets with clinical or genetic diagnosis of syndromic thoracic aortic aneurysms

Treatment:

Device: Pulsotonometry

Non-syndromic TAA

Description:

Subjets without clinical or genetic diagnosis of syndromic thoracic aortic aneurysms

Treatment:

Device: Pulsotonometry