UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027500 |
|---|---|
| Receipt number | R000031521 |
| Scientific Title | 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). |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2017/12/28 15:03:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
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).
Acronym
Secondary analysis of PROST
Scientific Title
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).
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Toshiaki Kadokami |
Organization
Fukuoka Saiseikai Futsukaichi Hospital
Division name
Department of Cardiology
Zip code
Address
3-13-1 Yu-machi, Chikushino, Fukuoka 818-0058, Japan
TEL
092-923-1551
t-kadokami@saiseikai-futsukaichi.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Tobushi |
Organization
Fukuoka Saiseikai Futsukaichi Hospital
Division name
Department of Cardiology
Zip code
Address
3-13-1 Yu-machi, Chikushino, Fukuoka 818-0058, Japan
TEL
092-923-1551
Homepage URL
ttobushi@gmail.com
Sponsor or person
Institute
Department of Cardiology, Fukuoka Saiseikai Futsukaichi Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031521
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
