Effects of Ulcerative Colitis Treatments on Heart Health
Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
This study is testing how different treatments for ulcerative colitis might affect heart health over time.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Drugs / interventions | infliximab, adalimumab, golimumab, vedolizumab, tofacitinib |
| Locations | 1 site (Amiens) |
| Trial ID | NCT04743518 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with recent cardiovascular events, diabetes, or those unable to provide consent may not benefit from this study.
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 performed: While the cardiovascular effects of ulcerative colitis treatments are not extensively studied, similar investigations into inflammatory bowel disease treatments have shown promising results.
Eligibility criteria
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 this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Mathurin Fumery, Pr
- Email: Fumery.mathurin@chu-amiens.fr
- Phone: 03 22 08 88 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.