UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014255 |
|---|---|
| Receipt number | R000014723 |
| Scientific Title | Examination of aortic diameter changes in patients after thoracic aortic aneurysm surgery with olmesartan or olmesartan + eplerenone |
| Date of disclosure of the study information | 2014/06/13 |
| Last modified on | 2015/07/16 18:20:25 |
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Basic information
Public title
Examination of aortic diameter changes in patients after thoracic aortic aneurysm surgery with olmesartan or olmesartan + eplerenone
Acronym
EXPORT trial
Scientific Title
Examination of aortic diameter changes in patients after thoracic aortic aneurysm surgery with olmesartan or olmesartan + eplerenone
Scientific Title:Acronym
EXPORT trial
Region
| Japan |
Condition
Condition
thoracic aortic aneurysm with hypertension
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients after thoracic aortic aneurysm surgery, we think that they remain to have arteriosclerotic changes at residual self-aorta. The purpose of this trial is to investigate the preventive effects to aortic expansion in patients after thoracic aortic aneurysm surgery with olmesartan or olmesartan + eprelenon by ways to measure the residual aortic diameter changes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
residual aortic diameter changes in contrast CT images after two years from thoracic aortic aneurysm surgery
Key secondary outcomes
changes in CAVI(cardio ankle vascular index)
plasma aldosterone concentration
high-sensitive CRP
blood pressure in outpatient clinic
transthoracic echocardiogram
renal function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with hypertension after thoracic aneurysm surgery are started to take medicines following treatment groups at the point of recovering well from surgery. The patients in treatment groups of olmesartan take 20mg of olmesartan orally after breakfast once daily. If their doctor assesses that they should take more antihypertensive drugs, he prescribes additional drugs and decreases their systolic blood pressure of less than 130 mmHg and their diastolic blood pressure of less than 80 mm Hg. However, we restrict prescription of ARBs, ACEIs and antialdosterone drugs. Patients continue to take this medicines for two yaers at least.
Interventions/Control_2
Patients with hypertension after thoracic aneurysm surgery are started to take medicines following treatment groups at the point of recovering well from surgery. The patients in treatment groups of olmesartan+eplerenone take 20mg of olmesartan and 25mg of eplerenone orally after breakfast once daily. If their doctor assesses that they should take more antihypertensive drugs, he prescribes additional drugs and decreases their systolic blood pressure of less than 130 mmHg and their diastolic blood pressure of less than 80 mm Hg. However, we restrict prescription of ARBs, ACEIs and antialdosterone drugs. Patients continue to take this medicines for two yaers at least.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hypertension after thoracic aneurysm surgery are selected for targets of this trial and registered with this trial. We don't care about types of aneurysm and sorts of surgery.The definition of hypertension is a systolic blood pressure of more than 140 mmHg or a diastolic blood pressure of more than 90 mm Hg on the basis of hypertension guidelines
Key exclusion criteria
"Patients with thoracic aneurysm induced from congenital connective tissue disorder such as Marfan's syndrome"
"Patients with thoracic aneurysm induced from autoimmune disorder such as aortitis syndrome"
"Patients with chronic renal failure, which is more than 2.0mg/dL of serum creatinine concentration, or more than 2g of protein in urine daily"
"Patients restricted to take olmesartan or eplerenone"
"Patients during pregnancy or expecting to get pregnant"
"Patients younger than 20"
"Patinets refusing to anticipate this trial"
"Patients which we judged unsuitable for this trial"
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikatsu Saiki |
Organization
Tohoku University School of Medicine
Division name
Dept. Cardiovascular Surgery
Zip code
Address
2-1,Seiryo-machi,Aoba-ward,Sendai,Miyagi,980-8575,Japan
TEL
022-717-7222
yoshisaiki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiichirou Kumagai |
Organization
Tohoku University School of Medicine
Division name
Dept. Cardiovascular Surgery
Zip code
Address
2-1,Seiryo-machi,Aoba-ward,Sendai,Miyagi,980-8575,Japan
TEL
022-717-7222
Homepage URL
kkumagai@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery,Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
nothing
Name of secondary funder(s)
nothing
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学病院（宮城県）
Tohoku University Hospital(Miyagi)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 13 | Day |
Last modified on
| 2015 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014723
