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Comparison of Beta-blocker Versus Angiotensin Receptor Blocker for Suppression of Aneurysm Expansion in Patients With Small Abdominal Aortic Aneurysm and Hypertension (BASE Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01904981
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : March 28, 2019
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Small Abdominal Aortic Aneurysm Drug: Beta-blocker-Atenolol 50mg, PO(peroral), Once daily Drug: Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : April 18, 2017
Actual Study Completion Date : April 18, 2017

Arm Intervention/treatment
Experimental: Atenolol
Atenolol group
Drug: Beta-blocker-Atenolol 50mg, PO(peroral), Once daily
Experimental: Valsartan
Valsartan group
Drug: Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily

Primary Outcome Measures :
  1. Annual aneurysm growth of abdominal aortic aneurysm [ Time Frame: at 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01904981

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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University Identifier: NCT01904981    
Other Study ID Numbers: 4-2012-0843
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Angiotensin Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents