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

March 26, 2019 updated by: Yonsei University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annual aneurysm growth of abdominal aortic aneurysm
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 18, 2017

Study Completion (Actual)

April 18, 2017

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0843

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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