Small Abdominal Aortic Aneurysm | Comparison of Beta-blocker Versus Angiotensin Receptor Blocker for Suppression of Aneurysm Expansion in Patients With Small Abdominal Aortic Aneurysm and Hypertension (BASE Trial)
Small Abdominal Aortic Aneurysm research study
What is the primary objective of this study?
Various medical therapies have been proposed to prevent abdominal aortic aneurysm expansion. However, there have been very few randomized clinical trials to support use of any of these treatments. Several animal studies and observational reports suggest that ARBs can be useful in reducing abdominal aortic aneurysm (AAA) growth. However, so far, ARBs have not been evaluated in a randomized clinical trial. Therefore, the purpose of the study is to evaluate the effect of valsartan, an ARB, on annual growth rate in comparison with atenolol, a beta-blocker. Our hypothesis is that valsartan is superior to atenolol in the suppression of the aneurysm growth at 12 months. The BASE trial is designed as a investigator-initiated, multi-center, randomized controlled open-label trial. Patients with small AAA (aorta diameter <5cm) will be randomized 1:1 either to valsartan or to atenolol group. Randomization will be stratified by the AAA size (max. diameter >4 cm or ≤4 cm). Patients will receive either valsartan (daily dose 80 mg or more) or atenolol (daily dose 50 mg or more) for 12 months. A CT scan will measure the maximal diameter of AAA at baseline and 12 months. The annual growth of AAA will be compared between the valsartan and the atenolol group.
Who is eligible to participate?
Inclusion Criteria: - Age ≥20years - Abdominal aortic aneurysm with maximal diameter less than 5cm - Hypertension - Patient with signed informed consent Exclusion Criteria: - Saccular type aneurysm, inflammatory aneurysm, or infected aneurysm - Aortic dissection - Planned surgery or endovascular therapy for abdominal aortic aneurysm within 1 year - Previous aorta surgery or endovascular therapy - Contraindications to Beta-blocker or ARB (allergic reactions, asthma, severe bradycardia, angioedema, hyperkalemia) - Allergic reaction to contrast dye - Known genetic aorta disease or autoimmune or connective tissue disease: Marfan syndrome, Shprintzen-Goldberg syndrome, Loeys-Dietz syndrome, Takayasu's arteritis, Behcet's disease - Pregnancy - Life expectation <1 year - Renal failure (serum Cr >2.0 mg/dL) - Liver disease (ALT or AST > 3 x upper limit) or liver cirrhosis (Child B or C) - Malignancy requiring surgery or chemotherapy within 1 year after enrollment - Status post transplantation or chronic inflammatory disease requiring immune suppressive drugs over 4 weeks
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Small Abdominal Aortic Aneurysm
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Beta-blocker-Atenolol 50mg, PO(peroral), Once daily
Drug:Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2013
Completed Date: October 2016
Phase: Phase 4
Primary Outcome: Annual aneurysm growth of abdominal aortic aneurysm
Study sponsors, principal investigator, and references
Lead Sponsor: Yonsei University