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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035343
Receipt No. R000036917
Scientific Title Effects of Sodium Restriction on Sleep Apnea in patients with Heart Failure; Randomized Controlled Study
Date of disclosure of the study information 2018/12/22
Last modified on 2018/12/22

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Basic information
Public title Effects of Sodium Restriction on Sleep Apnea in patients with Heart Failure; Randomized Controlled Study
Acronym SS-HF trial
Scientific Title Effects of Sodium Restriction on Sleep Apnea in patients with Heart Failure; Randomized Controlled Study
Scientific Title:Acronym SS-HF trial
Region
Japan

Condition
Condition Heart failure, Sleep apnea
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Purpose of this study is to examine the effects of sodium restriction on overnight rostral fluid shift and sleep apnea in patients with heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of sleep apnea severity, laboratory data, echocardiography findings and fluid shift volume following intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 4 days of Sodium restriction: 3g/day
Interventions/Control_2 4 days of Sodium restriction: 6g/day
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

Not applicable
Gender Male and Female
Key inclusion criteria Heart failure patients with moderate-severe sleep apnea (apnea-hypopnea index 10 or higher)
Key exclusion criteria 1. patients who need oxygen or any respiratory support
2. patients who are pregnant
3. dialysis
Target sample size 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kasai Takatoshi
Organization Juntendo University
Division name Department of Cardiology, Cardiovascular respiratory sleep medicine
Zip code
Address 3-1-3 Hongo Bunkyo-ku Tokyo
TEL 03-3813-3111
Email kasai-t@mx6.nisiq.net

Public contact
Name of contact person
1st name
Middle name
Last name Kurita Azusa
Organization Juntendo University
Division name Department of Cardiology
Zip code
Address 3-1-3 Hongo Bunkyo-ku Tokyo
TEL 03-3813-3111
Homepage URL
Email azmurata@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 12 Month 22 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
2018 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 05 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
2018 Year 12 Month 22 Day
Last modified on
2018 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036917

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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