UMIN-CTR Clinical Trial

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
Email	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
Email	sakurasoma1209@yahoo.co.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046317