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

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Other: Aortic pulse wave velocity; Other: carotid intima media thickness (CIMT)

• Registration Number: NCT04743518
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-02
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Primary Completion: 2023-12
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vedolizumab	Aortic pulse wave velocity	-
tofacitinib	Aortic pulse wave velocity	-
anti-TNF	Aortic pulse wave velocity	-
anti-TNF	carotid intima media thickness (CIMT)	-
vedolizumab	carotid intima media thickness (CIMT)	-
tofacitinib	carotid intima media thickness (CIMT)	-

Primary Outcome Measures

Name	Time	Method
variation of carotid intima media thickness (CIMT) between the 3 patient groups	at the end of month 3

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France