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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005719
Receipt No. 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

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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
Email 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
Email semiyontd17@gmail.com

Sponsor
Institute Anjo Kosei Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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