TElmisartan in the management of abDominal aortic aneurYsm (TEDY)

Phase 2

Completed

Conditions: abdominal aortic aneurysm. aneurysm
10002363

Registration Number: NL-OMON43808

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

AAA measuring a maximum diameter of 35-49 mm on CTA or ultrasound
No current indication for AAA repair according to the treating physician or expectation that this will be revised within the next year
High likelihood of compliance with treatment over 24 months

Exclusion Criteria

Contraindications to study treatment, including: renal impairment (i.e. creatinine >1.5x upper limit of normal [ULN]), known significant renal stenosis (>70%) of one or both renal arteries, chronic liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function (i.e. ALT 1.5xULN), electrolyte imbalance and gout. No previous abdominal aortic surgery.
Current or planned usage of an AT1 blocker or ACE inhibitors

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be the rate of growth of the AAAs estimated<br /><br>using the maximum orthogonal AAA diameter measured during the 2-year study<br /><br>period (ultrasound) and the change in total infrarenal volume. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>I. Change in maximum infrarenal AAA diameter on repeat ultrasound at entry, 6,<br /><br>12, 18 & 24 months;<br /><br>II. Change in serum OPG, OPN, MMP-9 and TGFbeta-1 on repeated samples over 24<br /><br>months;<br /><br>III. Quality of life assessed by the SF36 (Quality of Life) questionnaire<br /><br>completed at entry, 12 & 24 months, which we have previously validated for use<br /><br>in elderly participants [62-64];<br /><br>IV. There is increasing evidence that the efficacy of medications vary between<br /><br>individuals, with a growing interest in pharmacogenetics [75]. We have<br /><br>previously shown an association between genetic polymorphism in AT1 and AAA<br /><br>[43]. We will assess the presence of the AT1 1166C single nucleotide<br /><br>polymorphism (previously consistently associated with AAA) in recruited<br /><br>participants. This will enable us to analyse the impact of this polymorphism on<br /><br>response to telmisartan. </p><br>