Recruiting

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

NCT04743518 · Centre Hospitalier Universitaire, Amiens

Recruiting

In plain English

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About this study

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.

Eligibility criteria

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

Enrollment target: 100 participants

Allocation: randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2021-02-02

Estimated completion: 2025-12

Last updated: 2025-05-29

Interventions

Other: Aortic pulse wave velocityOther: carotid intima media thickness (CIMT)

Primary outcomes

• variation of carotid intima media thickness (CIMT) between the 3 patient groups (at the end of month 3)

Sponsor

Centre Hospitalier Universitaire, Amiens · other

Contacts & investigators

ContactMathurin Fumery, Pr · contact · Fumery.mathurin@chu-amiens.fr · 03 22 08 88 51

All locations (1)

CHU AmiensRecruiting

Amiens, France

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