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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04743518
Acronym
VASC-UC
Enrollment
100
Registered
2021-02-08
Start date
2021-02-02
Completion date
2025-12-31
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis, cardiovascular risk, CIMT

Brief 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.

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)

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
variation of carotid intima media thickness (CIMT) between the 3 patient groupsat the end of month 3

Countries

France

Contacts

Primary ContactMathurin Fumery, Pr
Fumery.mathurin@chu-amiens.fr03 22 08 88 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026