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

Centre Hospitalier Universitaire, Amiens

Status and phase: Enrolling; Phase 4

Conditions: Ulcerative Colitis

Treatments: Other: carotid intima media thickness (CIMT); Other: Aortic pulse wave velocity

Study type: Interventional

Funder types: Other

Identifiers

NCT04743518

PI2020_843_0114

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 3 patient groups

anti-TNF

Active Comparator group

Treatment:

Other: Aortic pulse wave velocity

Other: carotid intima media thickness (CIMT)

vedolizumab

Active Comparator group

Treatment:

Other: Aortic pulse wave velocity

Other: carotid intima media thickness (CIMT)

tofacitinib

Active Comparator group

Treatment:

Other: Aortic pulse wave velocity

Other: carotid intima media thickness (CIMT)