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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Drugs / interventions | infliximab, adalimumab, golimumab, vedolizumab, tofacitinib |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | February 2, 2021 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | May 29, 2025 |
| Trial ID | NCT04743518 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
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CHU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Mathurin Fumery, Pr
- Email: Fumery.mathurin@chu-amiens.fr
- Phone: 03 22 08 88 51
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.