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 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904981
• Other study ID #: 4-2012-0843
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: April 18, 2017

Study information

• Verified date: December 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 18, 2017
• Est. primary completion date: April 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Small Abdominal Aortic Aneurysm

Intervention

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

• Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual aneurysm growth of abdominal aortic aneurysm		at 12 months