Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
This study is investigating whether commonly used medications for ulcerative colitis (UC) impact heart health. People with UC can sometimes have a higher risk of heart and blood vessel problems. Researchers are looking at specific measures like the stiffness of your main artery (aorta) and the thickness of the blood vessels in your neck (carotid arteries). These measures can show if there's a higher chance of heart issues. The study aims to compare how different UC drugs – anti-TNF medicines, vedolizumab, and tofacitinib – affect these heart health markers over 3 and 12 months. They want to understand if these treatments help reduce any potential heart risks associated with UC.
At a glance
What is this study about?
If you have ulcerative colitis (UC), you might be more at risk of heart and blood vessel problems. This study wants to find out if the medicines you take for your UC have an effect on this risk. The researchers are particularly interested in certain types of UC drugs: anti-TNF medicines (like infliximab, adalimumab, golimumab), vedolizumab, and tofacitinib. They want to see how these treatments might change things related to heart health.
The study will look at two main things. One is called 'aortic pulse wave velocity,' which measures how stiff your main artery (the aorta) is. A stiffer artery can sometimes mean a higher risk of heart problems. The second is 'carotid intima media thickness' (CIMT), which measures the thickness of the blood vessels in your neck. If these blood vessels are thicker, it can also be a sign of a higher risk of heart issues. Both of these measurements are known to be higher in people with UC.
The main goal is to compare how these different UC medications affect your heart and blood vessels over time. Researchers will take these measurements before you start a new treatment, and then again after 3 months and 12 months. By doing this, they hope to learn if these important UC medicines can help improve or affect your heart health, which is really important for people living with ulcerative colitis.
Key takeaways
- Looks at how UC medicines affect heart health.
- Compares anti-TNF, vedolizumab, and tofacitinib.
- Measures artery stiffness and blood vessel thickness.
- Important for understanding future heart risks in UC.
- Involves assessments over 12 months.
Who may be eligible?
To join this study, you need to be an adult over 18 years old and have had ulcerative colitis for at least six months. You must also be about to start a new treatment with infliximab, adalimumab, golimumab, vedolizumab, or tofacitinib.
There are also some reasons why you might not be able to join. For example, if you've recently had a heart attack or a stroke, or if you have diabetes, you wouldn't be able to take part. Also, if you’re currently pregnant, you cannot join the study. We also can't include anyone who is already on medicines for blood pressure, blood thinning, or cholesterol, unless your dose has been stable for at least three months and will stay stable throughout the study.
Finally, all participants must be able to understand the study and agree to take part in writing.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you over 18 years old?
- Have you had ulcerative colitis for at least 6 months?
- Are you about to start a new anti-TNF, vedolizumab, or tofacitinib treatment?
- Do you not have diabetes, nor a recent heart attack or stroke?
- Are you not currently pregnant?
- Are your other medications (blood pressure, cholesterol, blood thinners) stable?
What does participation involve?
Taking part in this study would involve attending appointments at the start, and then again after 3 months and 12 months. At these appointments, researchers will take some measurements related to your heart and blood vessels. This will include measuring the stiffness of your main artery (aortic pulse wave velocity) and the thickness of the blood vessels in your neck (carotid intima media thickness). You'll continue taking your prescribed ulcerative colitis medication as planned by your doctor. The total duration of your participation in the study would be about 12 months.
Potential risks and benefits
Locations (1)
- CHU AmiensVerified postcodeAmiens, France· Recruiting
Common questions
What is 'aortic stiffness'?
Aortic stiffness refers to how firm your biggest artery (aorta) is. If it's too stiff, it can be a sign of a higher risk of heart problems.
What is 'carotid intima media thickness'?
This is a measurement of the thickness of the walls of the blood vessels in your neck. Thicker walls can sometimes suggest a higher risk of future heart issues.
Will this study change my ulcerative colitis treatment?
No, this study will not change the treatment plan for your ulcerative colitis. You will continue to receive the medicine your doctor has prescribed as usual.
Do I need to pay to be in the study?
No, you will not have to pay to participate in the study. All study-related tests and measurements will be provided without charge.
What if I decide I don't want to continue?
You are free to leave the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Mathurin Fumery, Pr
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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