UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040579 |
|---|---|
| Receipt number | R000046317 |
| Scientific Title | Effect of smoking on sympathetic nerve activity in heart failure |
| Date of disclosure of the study information | 2020/05/29 |
| Last modified on | 2020/05/29 15:59:17 |
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Basic information
Public title
Effect of smoking on sympathetic nerve activity in heart failure
Acronym
Smoking status in heart failure
Scientific Title
Effect of smoking on sympathetic nerve activity in heart failure
Scientific Title:Acronym
SMOKEHF
Region
| Japan |
Condition
Condition
heart failure patients
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is well-known that smoking habit contribute to cardiovascuoler event. smoking is also reported to Increased sympathetic nerve activity. Recently electrical cigarrete is spreading, but its effect on sympathetic nerve activity is unclear
Basic objectives2
Others
Basic objectives -Others
In this study, we examine the effect of electrical and nonelectrical smoking on muscle sympathetic nerve activity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
decrease in MSNA
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 | years-old | < |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
HF patients is defined as HF symptom, BNP>100pg/ml and left ventricular dysfunction before medication.
Smoking habit over 1years
Key exclusion criteria
1)diagnosis of HF within 1 month
2)Hemo-dialysis state
3)Uncontroled diabetes patients(HbA1c>8.0)
4)Severe autonomic dysfuntion
5)an inappropriate patient
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hisayoshi |
| Middle name | |
| Last name | Murai |
Organization
Katy Graduate School of Medical Sciencesnazawa University
Division name
Department of Cardiovascular Medicine
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa
TEL
076265200
sakurasoma1209@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hisayoshi |
| Middle name | |
| Last name | Murai |
Organization
Katy Graduate School of Medical Sciencesnazawa University
Division name
Department of Cardiovascular Medicine
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa
TEL
076265200
Homepage URL
sakurasoma1209@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Institutional Review Board
Address
13-1 Takara-machi, Kanazawa
Tel
0762652110
rinri@adm.kanazawa-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2019-077 (3116)
Org. issuing International ID_1
2019-077 (3116)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046317
