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

Investigation of the Neurovegetative Pattern in the Adult Population With Thoracic Aortic Aneurysms (AAT)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05703893
Acronym
IPaNeMA
Enrollment
139
Registered
2023-01-30
Start date
2021-11-09
Completion date
2026-01-31
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 Aneurysm, Thoracic, Rare Diseases

Keywords

Thoracic Aneurysms, Heart rate Variability, Autonomic Nervous System

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.

Interventions

DIAGNOSTIC_TESTSupine resting (REST) and active standing (STAND)

Analysis of baroreflex sensitivity

Sponsors

Politecnico di Milano
CollaboratorOTHER
IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Supine resting (REST) and active standing (STAND)18 monthsBaroreflex sensitivity

Countries

Italy

Outcome results

None listed

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