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NCT04743518 Clinical Trial

Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— VASC-UC  

Official title:
Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04743518
Other study ID # PI2020_843_0114
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2, 2021
Est. completion date February 2024

Study information
Verified date March 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Mathurin Fumery, Pr
Phone 03 22 08 88 51
Email Fumery.mathurin@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date February 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ulcerative colitis evolving for at least 6 months, - Patient older than 18 years, - Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib, - Written informed consent. Exclusion Criteria: - Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period, - Patients with a cardiovascular event such as myocardial infarction and stroke, - Diabetic patient, - Pregnant women, - Minor - people unable to give their consent to participate

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Aortic pulse wave velocity
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness
• carotid intima media thickness (CIMT)
carotid intima media thickness (CIMT)

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary variation of carotid intima media thickness (CIMT) between the 3 patient groups at the end of month 3
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