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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904981
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE July 17, 2013
First Posted Date  ICMJE July 22, 2013
Last Update Posted Date March 28, 2019
Study Start Date  ICMJE January 2014
Actual Primary Completion Date April 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
Annual aneurysm growth of abdominal aortic aneurysm [ Time Frame: at 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01904981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Beta-blocker Versus Angiotensin Receptor Blocker for Suppression of Aneurysm Expansion in Patients With Small Abdominal Aortic Aneurysm and Hypertension (BASE Trial)
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Abdominal Aortic Aneurysm
Intervention  ICMJE
  • Drug: Beta-blocker-Atenolol 50mg, PO(peroral), Once daily
  • Drug: Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily
Study Arms  ICMJE
  • Experimental: Atenolol
    Atenolol group
    Intervention: Drug: Beta-blocker-Atenolol 50mg, PO(peroral), Once daily
  • Experimental: Valsartan
    Valsartan group
    Intervention: Drug: Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2013)
400
Actual Study Completion Date  ICMJE April 18, 2017
Actual Primary Completion Date April 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01904981
Other Study ID Numbers  ICMJE 4-2012-0843
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP