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

S

San Donato Group (GSD)

Status

Active, not recruiting

Conditions

Aortic Aneurysm, Thoracic
Rare Diseases

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT05703893
IPaNeMA

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

139 participants in 2 patient groups

Syndromic TAA
Description:
Patients presenting either clinical or genetic phenotype referring to a syndrome related to Thoracic Aortic Aneurysms
Treatment:
Diagnostic Test: Supine resting (REST) and active standing (STAND)
Non-syndromic TAA
Description:
Patients presenting Thoracic Aortic Aneurysms
Treatment:
Diagnostic Test: Supine resting (REST) and active standing (STAND)

Trial contacts and locations

1

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Central trial contact

Alessandro Pini, MD

Data sourced from clinicaltrials.gov

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