Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)

Recruiting

• Conditions: Aortic Aneurysm, Thoracic; Rare Diseases
• Interventions: Diagnostic Test: Supine resting (REST) and active standing (STAND)

• Registration Number: NCT05703893
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief Summary

The goal of this observational cross-sectional study is to learn about vagal features in patients with syndromic and non-syndromic TAA. The main question it aims to answer is to highlight a functional condition that could help stratify patients with TAA on the risk of aortic complications.

Participant will take part by standing in supine position for 10 minutes and during active standing for 10 minutes. In this period of time, it will be possible to acquire the signals continuously and non invasively through recorded non-invasive blood pressure and piezoelectric sensor breathing belt.

Detailed Description

Changes in blood pressure (BP) are tightly controlled by a neural surveillance system that triggers changes in response to heart rate, vascular tone, and respiration.

Therefore, studies in literature have investigated the regulatory effects of the sympathetic system on the tone of the vessels as well as on the BP, but further analysis are needed in order to describe its potential impact on the structure of the aortic wall and, in particular, its potential implications on aneurysms and risk of aortic dissections.

Considering that, in the population with TAA, the neurovegetative pattern influences the responses to different stressors (environmental, occupational and emotional) and also acts on the BP, which represents a risk factor for the TAA population, its analysis would allow to identify attitudes and behavioral predispositions and therefore response to stressors.

The non-invasive analysis of sympatho-adrenergic patterns could help to highlight a functional condition related to the "environmental stressors" which could help to stratify patients with TAA based on the level of pathological reactivity with effects on risk of aortic complications.

Study Timeline

• Study Start: 2021-11-09
• Primary Completion: 2022-10-25
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Study Completion: 2024-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• Patients aged 18-65 years with syndromic and nonsyndromic TAA;
• Signed informed consent;
• Patients on regular pharmacological prophylaxis (with Losartan) or naïve patients with a first diagnosis

Exclusion Criteria

• Acute and chronic inflammatory diseases such as: liver disease, chronic renal insufficiency (creatinine > 1.5 mg/dl) and diseases affecting the thyroid system.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Syndromic TAA	Supine resting (REST) and active standing (STAND)	Patients presenting either clinical or genetic phenotype referring to a syndrome related to Thoracic Aortic Aneurysms
Non-syndromic TAA	Supine resting (REST) and active standing (STAND)	Patients presenting Thoracic Aortic Aneurysms

Primary Outcome Measures

Name	Time	Method
Supine resting (REST) and active standing (STAND)	18 months	Baroreflex sensitivity

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Lombardia, Italy