Ignite Creation Date:
2024-05-06 @ 1:50 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01904981
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2013-07-17
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
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None