Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Effects of Ulcerative Colitis Treatments on Heart Health

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

Run by Centre Hospitalier Universitaire, Amiens · NCT04743518 · Data updated 2026-11-12

This study is testing how different treatments for ulcerative colitis might affect heart health over time.

More Ulcerative Colitis trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorCentre Hospitalier Universitaire, Amiens
Academic / other
Drugs / interventionsinfliximab, adalimumab, golimumab, vedolizumab, tofacitinib
Locations1 site (Amiens)
StatusRecruiting
StartedFebruary 2, 2021
Main results expectedDecember 2025
Study endsDecember 2025
Registry record updatedMay 29, 2025
Trial IDNCT04743518 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with a diagnosis of ulcerative colitis for at least 6 months who are starting treatment with specific medications.

Probably not a fit

Patients with recent cardiovascular events, diabetes, or those unable to provide consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how treatments for ulcerative colitis, specifically anti-TNF agents, vedolizumab, and tofacitinib, affect cardiovascular risk factors such as aortic stiffness and carotid intima-media thickness. It aims to measure these cardiovascular indicators at baseline and after 3 and 12 months of treatment. By comparing these metrics, the study seeks to understand the potential cardiovascular benefits or risks associated with these medications in patients with ulcerative colitis.

Why it matters

Potential benefit: If successful, this study could help identify safer treatment options for ulcerative colitis patients that minimize cardiovascular risks.

How similar studies have gone: While the cardiovascular effects of ulcerative colitis treatments are not extensively studied, similar investigations into inflammatory bowel disease treatments have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • CHU Amiens
    Amiens, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.