UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Sodium Restriction on Sleep Apnea in patients with Heart Failure; Randomized Controlled Study
Title of the study (Brief title)	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	Kasai Takatoshi
Organization	Juntendo University
Division name	Department of Cardiology, Cardiovascular respiratory sleep medicine
Address	3-1-3 Hongo Bunkyo-ku Tokyo
TEL	03-3813-3111
Email	kasai-t@mx6.nisiq.net

Public contact
Name of contact person	Kurita Azusa
Organization	Juntendo University
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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