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

NCT01904981 | Completed Phase 4 DMC

• 1 other identifier: 4-2012-0843
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Annual aneurysm growth of abdominal aortic aneurysm

  at 12 months

Study Arms (2)

Atenolol

EXPERIMENTAL

Atenolol group

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

Valsartan

EXPERIMENTAL

Valsartan group

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

Interventions

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

Atenolol

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

Valsartan

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥20years
• Abdominal aortic aneurysm with maximal diameter less than 5cm
• Hypertension
• Patient with signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: January 1, 2014
• Primary Completion: April 18, 2017
• Study Completion: April 18, 2017
• Last Updated: March 28, 2019

Record last verified: 2018-12

Locations

KR (1)