DOI: http://dx.doi.org/10.18203/2349-3259.ijct20163960

Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME)-2: the study protocol for a multi-centre, randomised, placebo-controlled trial

Sophie E. Rowbotham, Bernie Bourke, Michael Bourke, Rene Jaeggi, Jason S. Jenkins, Joseph V. Moxon, Jenna L. Pinchbeck, Christopher M. Reid, Ramesh Velu, Jonathan Golledge

Abstract


Background: Abdominal aortic aneurysms (AAAs) are a leading cause of mortality worldwide but have no recognised medical therapy. Pre-clinical studies indicate that osteopontin plays an important role in the pathogenesis of AAA via a number of mechanisms. This trial aims to assess the potential of fenofibrate to favourably alter biomarkers associated with AAA pathology.

Methods: Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME)-2 is a multi-centre, prospective, randomised, double-blind, placebo-controlled clinical trial to assess the effect of 24 weeks of oral therapy with 145 mg of fenofibrate on key pathological markers of AAA. A total of 140 participants with an AAA measuring between 35-49 mm will be randomly assigned to either 145 mg of fenofibrate once per day or identical placebo for a period of 24 weeks. Primary outcome measures will be serum concentrations of osteopontin and kallistatin. Secondary outcome measures will include serum levels of resistin, lipids, matrix metalloproteinases and pro-inflammatory cytokines, circulating concentrations of AAA biomarkers, and AAA diameter as assessed by ultrasound.

Conclusions: This study represents the next step in the assessment of a potential novel medical therapy for AAA.


Keywords


Abdominal aortic aneurysm, Fenofibrate, Clinical trial, Osteopontin, Kallistatin

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References


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