UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005719 |
|---|---|
| Receipt number | R000006760 |
| Scientific Title | Effect of direct renin inhibitor(Aliskiren) in chronic heart failure patient with hypertension |
| Date of disclosure of the study information | 2011/06/04 |
| Last modified on | 2013/09/02 23:06:48 |
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Basic information
Public title
Effect of direct renin inhibitor(Aliskiren) in chronic heart failure patient with hypertension
Acronym
Effect of direct renin inhibitor(Aliskiren) in chronic heart failure patient with hypertension
Scientific Title
Effect of direct renin inhibitor(Aliskiren) in chronic heart failure patient with hypertension
Scientific Title:Acronym
Effect of direct renin inhibitor(Aliskiren) in chronic heart failure patient with hypertension
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of switching from Angiotensin II receptor blockers to direct renin inhibitor(Aliskiren) in chronic heart failure patient with hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum brain natriuretic peptide level
Key secondary outcomes
Changes in LVEF,blood pressure,PRA,plasma aldosterone level,serum potassium level,eGFR,serum creatinine level,albuminuria,uric acid level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Observing during one year after changing to aliskiren 150mg/day from ARB
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patient who is in stable control at registration
2)Patient who is not taking aliskiren within one month before registration
3)Patient who is taking ARB of standard dosage
4)Patient who obtained agreement by free will of patient himself on full understanding after enough explanation
Key exclusion criteria
1)Patient who has hypersensitivity and the past in direct renin inhibitor
2)Patient treated by ACE inhibitor
3)Patient with poor control of diabetic mellitus(HbA1c 9% or more)
4)Patient with unstable angina pectoris or who has the past history of acute myocardial infarction and cerebral infarction within three months
5)Patient with LVEF<30%
6)Patient who has serious liver disease (child classification C or more)
7)Patient who has serious kidney disease
8)Patient who is taking medicine of contraindication of using together
9)Woman who has possibility of pregnancy or getting pregnant
10)Breast-feeding woman
11)Patient with hyperkalemia(5.5mEq/L or more)
12)Patient of eGFR<30mL/min/1.73 m2
13)Additionally, patient who judged to be improper as testee
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Watarai |
Organization
Anjo Kosei Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
28,Higasi-Hirokute,Anjo-Cho,Anjo,446-8602,Japan
TEL
0566-75-2111
watarai@kosei.anjo.aichi.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadahiro Ito |
Organization
Anjo Kosei Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
28,Higasi-Hirokute,Anjo-Cho,Anjo,446-8602,Japan
TEL
0566-75-2111
Homepage URL
semiyontd17@gmail.com
Sponsor or person
Institute
Anjo Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
Anjo Kosei Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 04 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 04 | Day |
Last modified on
| 2013 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006760
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
