Completed

NCT Number: NCT01904981

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

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.

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Key information

Conditions

Small Abdominal Aortic Aneurysm

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Drug

Primary outcomes

Annual aneurysm growth of abdominal aortic aneurysm

Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jul 22, 2013
Registry last updated: Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.