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

March 9, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80480
        • Recruiting
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: anti-TNF
Other: Aortic pulse wave velocity
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness
Other: carotid intima media thickness (CIMT)
carotid intima media thickness (CIMT)
Active Comparator: vedolizumab
Other: Aortic pulse wave velocity
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness
Other: carotid intima media thickness (CIMT)
carotid intima media thickness (CIMT)
Active Comparator: tofacitinib
Other: Aortic pulse wave velocity
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness
Other: carotid intima media thickness (CIMT)
carotid intima media thickness (CIMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
variation of carotid intima media thickness (CIMT) between the 3 patient groups
Time Frame: at the end of month 3
at the end of month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2020_843_0114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis

Clinical Trials on Aortic pulse wave velocity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe