Small Abdominal Aortic AneurysmPhase 4NCT01904981
Comparison of Beta-blocker Versus Angiotensin Receptor Blocker for Suppression of Aneurysm Expansion in Patients With Small Abdominal Aortic Aneurysm and Hypertension (BASE Trial)
A Phase 4 study testing Beta-blocker-Atenolol 50mg, PO(peroral), Once daily and Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily in people with Small Abdominal Aortic Aneurysm, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Small Abdominal Aortic Aneurysm
- What is being tested?
- Beta-blocker-Atenolol 50mg, PO(peroral), Once daily and Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to 18 Apr 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20years
- Abdominal aortic aneurysm with maximal diameter less than 5cm
- Hypertension
- Patient with signed informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Beta-blocker-Atenolol 50mg, PO(peroral), Once daily, Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-blocker-Atenolol 50mg, PO(peroral), Once dailyDrug
Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once dailyDrug
| Study group | Role | What they receive |
|---|---|---|
| Atenolol | Experimental | Atenolol group Receives: Drug: Beta-blocker-Atenolol 50mg, PO(peroral), Once daily |
| Valsartan | Experimental | Valsartan group Receives: Drug: Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual aneurysm growth of abdominal aortic aneurysm
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startJan 2014
- Primary completion18 Apr 2017
- Study completion18 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904981
- Sponsor's protocol ID
- 4-2012-0843
- Status last verified
- Dec 2018
- First submitted
- 17 Jul 2013
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01904981
- Acronym / sponsor ID
- 4-2012-0843
- Conditions
- Small Abdominal Aortic Aneurysm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atenolol | Experimental | Drug: Beta-blocker-Atenolol 50mg, PO(peroral), Once dailyAtenolol group |
| Valsartan | Experimental | Drug: Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once dailyValsartan group |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥20years
- Abdominal aortic aneurysm with maximal diameter less than 5cm
- Hypertension
- Patient with signed informed consent
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-blocker-Atenolol 50mg, PO(peroral), Once daily | Drug | Atenolol |
| Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily | Drug | Valsartan |
Primary outcome
Annual aneurysm growth of abdominal aortic aneurysm
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta-blocker-Atenolol 50mg, PO(peroral), Once daily and Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily in people with Small Abdominal Aortic Aneurysm, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual aneurysm growth of abdominal aortic aneurysm (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.