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

Rowbotham, Sophie E., Bourke, Bernie, Bourke, Michael, Jaeggi, Rene, Jenkins, Jason S., Moxon, Joseph V., Pinchbeck, Jenna L., Reid, Christopher M., Velu, Ramesh, and Golledge, Jonathan (2016) Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME)-2: the study protocol for a multi-centre, randomised, placebo-controlled trial. International Journal of Clinical Trials, 3 (4). pp. 217-224.

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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.

Item ID: 46417
Item Type: Article (Research - C1)
ISSN: 2349-3259
Keywords: abdominal aortic aneurysm, fenofibrate, clinical trial, osteopontin, kallistatin
Additional Information:

© the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Funders: National Health and Medical Research Council (NHMRC), Queensland Government (QG)
Projects and Grants: NHMRC 1079369, NHMRC 1000967, NHMRC 1019921, QG Senior Clinical Research Fellowship
Date Deposited: 21 Nov 2016 03:49
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1102 Cardiovascular Medicine and Haematology > 110201 Cardiology (incl Cardiovascular Diseases) @ 100%
SEO Codes: 92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920103 Cardiovascular System and Diseases @ 100%
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