RecruitingPhase 4NCT04743518

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


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

100 participants

Start Date

Feb 2, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

Interventions

OTHERAortic pulse wave velocity

Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness

OTHERcarotid intima media thickness (CIMT)

carotid intima media thickness (CIMT)


Locations(1)

CHU Amiens

Amiens, France

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NCT04743518


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