UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010119 |
|---|---|
| Receipt number | 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 22:02:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Internal Medicine, Kanazawa University Hospital Disease Control and Homeostasis
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011849
