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

Rare Diseases Clinical Trial

— IPaNeMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703893
• Other study ID #: IPaNeMA
• Status: Recruiting
• Start date: November 9, 2021
• Est. completion date: December 25, 2024

Study information

• Verified date: March 2024
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 139
• Est. completion date: December 25, 2024
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Rare Diseases

Intervention

Diagnostic Test:
• Supine resting (REST) and active standing (STAND)
Analysis of baroreflex sensitivity

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato	Politecnico di Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supine resting (REST) and active standing (STAND)	Baroreflex sensitivity	18 months