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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05703893
Other study ID # IPaNeMA
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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