Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis (VASC-UC)
Primary Purpose
Ulcerative Colitis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aortic pulse wave velocity
carotid intima media thickness (CIMT)
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring ulcerative colitis, cardiovascular risk, CIMT
Eligibility 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
Sites / Locations
- CHU AmiensRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
anti-TNF
vedolizumab
tofacitinib
Arm Description
Outcomes
Primary Outcome Measures
variation of carotid intima media thickness (CIMT) between the 3 patient groups
Secondary Outcome Measures
Full Information
NCT ID
NCT04743518
First Posted
February 3, 2021
Last Updated
March 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04743518
Brief Title
Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
Acronym
VASC-UC
Official Title
Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
ulcerative colitis, cardiovascular risk, CIMT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-TNF
Arm Type
Active Comparator
Arm Title
vedolizumab
Arm Type
Active Comparator
Arm Title
tofacitinib
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Aortic pulse wave velocity
Intervention Description
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness
Intervention Type
Other
Intervention Name(s)
carotid intima media thickness (CIMT)
Intervention Description
carotid intima media thickness (CIMT)
Primary Outcome Measure Information:
Title
variation of carotid intima media thickness (CIMT) between the 3 patient groups
Time Frame
at the end of month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathurin Fumery, Pr
Phone
03 22 08 88 51
Email
Fumery.mathurin@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathurin Fumery, Pr
Phone
03 22 08 88 51
Email
Fumery.mathurin@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Marie-Antoinette Sevestre, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
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