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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018611
Receipt No. R000021538
Scientific Title effect for sympathetic nerve activity of statin for heart failure with preserved ejection fraction
Date of disclosure of the study information 2015/09/01
Last modified on 2015/08/09

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Basic information
Public title effect for sympathetic nerve activity of statin for heart failure with preserved ejection fraction
Acronym effect for sympathetic nerve activity of statin for heart failure with preserved ejection fraction
Scientific Title effect for sympathetic nerve activity of statin for heart failure with preserved ejection fraction
Scientific Title:Acronym effect for sympathetic nerve activity of statin for heart failure with preserved ejection fraction
Region
Japan

Condition
Condition chronic heart failure with preserved ejection fraction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 investigation of sympathetic nerve of statin for HFpEF
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes regulation of muscle sympathetic nerve activity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 prescribe atrovastatin
Interventions/Control_2 prescribe lovastatin
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1) chronic heart failure with preserved EF( >40%)
2) dyslipidemia
Key exclusion criteria 1) stroke
2) AMI within 3 months
3) ACS
4) IP
5) severe valvular desease or shunt desease
6) chronic kidney desease
7)chronic Af
8) DM
9) secondary hypertension
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa University
Division name departmento of desease control and homeostasis
Zip code
Address 13-1, Takara-machi, Kanazawa, 920-8641, Japan
TEL 076-265-2000
Email hidekitokuhisa@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name hideki tokuhisa
Organization kanazawa university
Division name department of desease control and homeostasis
Zip code
Address 13-1, Takara-machi, Kanazawa, K
TEL 090-2379-7809
Homepage URL
Email hidekitokuhisa@yahoo.co.jp

Sponsor
Institute Kanazawa university
Institute
Department

Funding Source
Organization Kanazawa university
Organization
Division
Category of Funding Organization Other
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
2015 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2015 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 09 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
2015 Year 08 Month 09 Day
Last modified on
2015 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021538

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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