UMIN-CTR Clinical Trial

Basic information
Public title	Multi-center pilot study examining a procedure to measure LFCT in heart failure patients.
Acronym	Multi-center pilot study examining a procedure to measure LFCT in heart failure patients.
Scientific Title	Multi-center pilot study examining a procedure to measure LFCT in heart failure patients.
Scientific Title:Acronym	Multi-center pilot study examining a procedure to measure LFCT in heart failure patients.
Region	Japan

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

Objectives
Narrative objectives1	To examine whether the Lung-to-Finger Circulation Time(LFCT) measurement method, which was proved to be appropriate for healthy volunteers, is also applicable for patients with heart failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Variation in LFCT measurement
Key secondary outcomes	Rate of successful measurement of LFCT

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Four times repeated LFCT measurement using holding breathing for 20 sec
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	1.NYHA classification I-III , in the treatment of heart failure
Key exclusion criteria	1.Patients in acute phase of cardiovascular disease (<7 days) 2.Patients who need oxygen inhalation 3.Those on whom a measurement device cannot be equipped on the second and third finger of the right hand 4.Patients with impaired understanding or recognition 5.Patients with a permanent pacemaker 6.Patients under hemodialysis 7.Patients judged by the investigator as ineligible for this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shin-ichi Middle name Last name Ando
Organization	Kyushu University Hospital
Division name	Sleep Apnea Center
Zip code	812-8582
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	092-642-5987
Email	shinando@sleep.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Yasuko Middle name Last name Yoshioka
Organization	Kyushu University Hospital
Division name	Sleep Apnea Center
Zip code	812-8582
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	092-642-5988
Homepage URL
Email	y_yasuko@sleep.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	Fukuokaken Saiseikai Futsukaichi Hospital Institutional Review Board
Address	3-13-1 Yumachi Chikushino Fukuoka prefecture
Tel	092-923-1551
Email	info@saiseikai-futsukaichi.org

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	順天堂大学病院（東京都）、福岡県済生会二日市病院（福岡県）

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 10 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	50
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	Completed
Date of protocol fixation	2019 Year 07 Month 18 Day
Date of IRB	2019 Year 08 Month 01 Day
Anticipated trial start date	2019 Year 09 Month 12 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 01 Month 23 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 03 Day
Last modified on	2020 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043160