The effect of Telmisartan on inflammatory processes in the vascular wall of abdominal aortic aneurysms.

An abdominal aortic aneurysm is a balloon-shaped dilatation of the lower part
of the largest artery of the human body. An aneurysm gives almost no symptoms,
but the danger of an aneurysm is the potential risk of sudden tearing. This
leads to an life-threatening bleeding. Aneurysm rupture leads to an estimate of
800 deaths per year in the Netherlands and aneurysm treatment costs up to 50
million euro's per year. Causing aneurysm's to be an considerable health issue.

The chance of rupture is very small in smaller aneurysms however the chance
increases fast with larger diameters. There is a great need for medical
inhibition of aneurysm growth, since this will lead to fewer aneurysm
surgery's. Animal studies showed that angiotensin II antagonists can inhibit
aneurysm growth and development. In this observational intervention study we
would like to explore the effects of the angiotensin II antagonist Telmisartan
on inflammation in the human aneurysm wall. This study will run parallel to the
currently running study P12.094 "TEDY: Telmisartan in the management of
abdominal aortic aneurysm.", with number NL40515.058.12, in which the
potential clinical effect of Telmisartan on AAA growth is under evaluation.

In this study we would like to study the effects of the selective angiotensin
II antagonist Telmisartan on inflammation and cell/matrix homeostasis in the
human aneurysm aortic wall.

An observational intervention study in which 15 patients who are planned to
have elective aneurysm repair are requested to take a daily dose of 40 mg
Telmisartan 2 to 4 weeks prior to surgery. During surgery aneurysm tissue will
be collected and preserved. This does not extend the impact of the surgery nor
does it alter the recovery/care afterwards. The collected tissue samples will
then be analysed for markers for inflammation, cell proliferation and matrix
remodeling. Results will be compared to tissue samples from patients who have
been treated with an ACE inhibitor preoperatively and tissue for patients who
didn't receive preoperative treatment (controls). All samples for comparison
are already present in our biobank.

A daily dose of 40 mg Telmisartan (oral use) 2-4 weeks prior to aneurysm
surgery.

Participating in this study only entails daily use of Telmisartan 2-4 weeks
prior to surgery. The standard care is completely the same. Telmisartan is a
registered drug used for treating hypertension. Although most people won't
notice anything from using Telmisartan, side effects might occur. These are
almost always mild side effects like dizziness and cold hands/feet. Side
effects will resolve after stopping the study medication. To prevent any side
effects from occurring patients are advised to take the medication at night.