Rare Diseases Clinical Trial
— IPaNeMAOfficial title:
Investigation of the Neurovegetative Pattern in the Adult Population With Thoracic Aortic Aneurysms (AAT)
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Policlinico San Donato | San Donato Milanese | Lombardia |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Donato | Politecnico di Milano |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Supine resting (REST) and active standing (STAND) | Baroreflex sensitivity | 18 months |
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