Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04743518

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-29

100

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Amiens

Amiens, France, 80480

Actively Recruiting

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Research Team

M

Mathurin Fumery, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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