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

NCT05703893 | Active Not Recruiting DMC

• 1 other identifier: IPaNeMA
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Rare Diseases; Aortic Aneurysm, Thoracic

Keywords

Thoracic Aneurysms; Heart rate Variability; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• Supine resting (REST) and active standing (STAND)

  Baroreflex sensitivity

  18 months

Study Arms (2)

Syndromic TAA

Patients presenting either clinical or genetic phenotype referring to a syndrome related to Thoracic Aortic Aneurysms

Diagnostic Test: Supine resting (REST) and active standing (STAND)

Non-syndromic TAA

Patients presenting Thoracic Aortic Aneurysms

Diagnostic Test: Supine resting (REST) and active standing (STAND)

Interventions

Supine resting (REST) and active standing (STAND) DIAGNOSTIC_TEST

Analysis of baroreflex sensitivity

Non-syndromic TAA; Syndromic TAA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic, hospitals.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead
• Politecnico di Milano: collaborator

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Lombardy, 20097, Italy

Location

MeSH Terms

Conditions

Rare Diseases; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 30, 2023
• Study Start: November 9, 2021
• Primary Completion: October 25, 2024
• Study Completion: January 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

IT (1)