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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010119
Receipt No. R000011849
Scientific Title Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients
Date of disclosure of the study information 2013/03/01
Last modified on 2013/02/25

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Basic information
Public title Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients
Acronym Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients
Scientific Title Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients
Scientific Title:Acronym Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients
Region
Japan

Condition
Condition Chronic heart failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess changes in cardiac adrenergic activity with cardiac resynchronization therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effect of cardiac resynchronization therapy on muscle sympathetic nerve activity, 24 and 48 week after implantation.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 weeks-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Twenty consecutive patients with advanced heart failure who meet clinical criteria for a CRT implantation ( LVEF<35%, NYHA function class 3 or 4, QRS durationz>120ms and optimal medical therapy).
Key exclusion criteria Patints with recent myocardial infarction, cardiac surgery(<3 months), unstable medical conition, and chronic atrial fibrillation are excluded.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Internal Medicine, Kanazawa University Hospital
Division name Disease Control and Homeostasis
Zip code
Address 13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2000
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Internal Medicine, Kanazawa University Hospital
Division name Disease Control and Homeostasis
Zip code
Address 13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2000
Homepage URL
Email

Sponsor
Institute Internal Medicine, Kanazawa University Hospital Disease Control and Homeostasis
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanazawa medical center
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 金沢大学附属病院(石川県)、金沢医療センター(石川県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 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
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 03 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 prospective study

Management information
Registered date
2013 Year 02 Month 25 Day
Last modified on
2013 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011849

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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