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

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Abdominal aortic aneurysm
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Brief Title

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

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Annual aneurysm growth of abdominal aortic aneurysm

Condition

Small Abdominal Aortic Aneurysm

Intervention

Beta-blocker-Atenolol 50mg, PO(peroral), Once daily

Study Arms / Comparison Groups

 Atenolol
Description:  Atenolol group

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

19

Start Date

January 2014

Completion Date

April 18, 2017

Primary Completion Date

April 18, 2017

Eligibility Criteria

        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

Gender

All

Ages

20 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations

NCT ID

NCT01904981

Organization ID

4-2012-0843

Responsible Party

Sponsor

Study Sponsor

Yonsei University

Study Sponsor

, ,

Verification Date

December 2018