UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Secondary analysis of "multicenter, prospective study on respiratory stability through recovery process from deterioration of heart failure in patients with chronic heart failure: PROST"(UMIN000019905).
Title of the study (Brief title)	Secondary analysis of PROST
Region	Japan

Condition
Condition	Chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The secondary analysis is carried out using data acquired from polysomnography in PROST, fixed and anonymized.
Basic objectives2	Others
Basic objectives -Others	We investigate a correlation between lung-to-finger circulation time (LFCT) and respiratory stability index (RSI), or between LFCT and other indices of heart failure and sleep apnea syndrome (SAS) before and after treatment.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between lung-to-finger circulation time (LFCT) recorded in polysomnography and respiratory stability index (RSI), other factors of heart failure and level of sleep apnea syndrome.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients enrolled in PROST
Key exclusion criteria	Nothing particular
Target sample size	44

Research contact person
Name of lead principal investigator	Toshiaki Kadokami
Organization	Fukuoka Saiseikai Futsukaichi Hospital
Division name	Department of Cardiology
Address	3-13-1 Yu-machi, Chikushino, Fukuoka 818-0058, Japan
TEL	092-923-1551
Email	t-kadokami@saiseikai-futsukaichi.org

Public contact
Name of contact person	Tomoyuki Tobushi
Organization	Fukuoka Saiseikai Futsukaichi Hospital
Division name	Department of Cardiology
Address	3-13-1 Yu-machi, Chikushino, Fukuoka 818-0058, Japan
TEL	092-923-1551
Homepage URL
Email	ttobushi@gmail.com

Sponsor
Institute	Department of Cardiology, Fukuoka Saiseikai Futsukaichi Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	福岡県済生会二日市病院（福岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 06 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	We investigate a correlation between LFCT and RSI or between LFCT and other indices of heart failure and sleep apnea syndrome (SAS) at pre-treatment and post-treatment. Other heart failure and SAS indices are as follows: 1) With/without congestion 2) Weight change 3) Saturation change 4) NYHA level 5) BNP level 6) AHI level 7) Mean SpO2 8) 3% SDI so on.

Management information
Registered date	2017 Year 05 Month 26 Day
Last modified on	2017 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031521