Clinical trial NCT05703893: Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
Official title: Investigation of the Neurovegetative Pattern in the Adult Population With Thoracic Aortic Aneurysms (AAT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Diseases
Aortic Aneurysm, Thoracic
Keywords: Thoracic Aneurysms
Heart rate Variability
Autonomic Nervous System
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
First posted: 2023-01-30
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, hospitals.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Supine resting (REST) and active standing (STAND)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Lombardia
Study officials:
References: