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

NCT04743518 | Recruiting Phase 4

• 1 other identifier: PI2020_843_0114
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis; cardiovascular risk; CIMT

Outcome Measures

Primary Outcomes (1)

• variation of carotid intima media thickness (CIMT) between the 3 patient groups

  at the end of month 3

Study Arms (3)

anti-TNF

ACTIVE COMPARATOR

Other: Aortic pulse wave velocity; Other: carotid intima media thickness (CIMT)

vedolizumab

ACTIVE COMPARATOR

Other: Aortic pulse wave velocity; Other: carotid intima media thickness (CIMT)

tofacitinib

ACTIVE COMPARATOR

Other: Aortic pulse wave velocity; Other: carotid intima media thickness (CIMT)

Interventions

Aortic pulse wave velocity OTHER

Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness

anti-TNF; tofacitinib; vedolizumab

carotid intima media thickness (CIMT) OTHER

carotid intima media thickness (CIMT)

anti-TNF; tofacitinib; vedolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Carotid Intima-Media Thickness

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography, Carotid Arteries; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Mathurin Fumery, Pr

CONTACT

03 22 08 88 51; Fumery.mathurin@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: February 2, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)