UMIN-CTR Clinical Trial

Basic information
Public title	Study on fluctuation of kidney biomarker at chronic heart failure patients given by remote ischemic preconditioning
Acronym	Study on the effect of remote ischemic preconditioning on kidney in patients with chronic heart failure
Scientific Title	Study on fluctuation of kidney biomarker at chronic heart failure patients given by remote ischemic preconditioning
Scientific Title:Acronym	Study on the effect of remote ischemic preconditioning on kidney in patients with chronic heart failure
Region	Japan

Condition
Condition	patients with chronic heart failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of kidney biomarker on remote ischemic preconditioning.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	urinary L-type fatty acid binding protein
Key secondary outcomes

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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Intervention group with remote ischemic preconditioning
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) Patients over 20 years of age (2) Patients with left ventricular ejection fraction less than 40% by echocardiography (3) Patients with oxygen saturation of 96% or more in room air (4) Patients for whom consent is documented for participation in this study (5) Patients who have consent to hospitalization for participation in this study
Key exclusion criteria	(1) Patients with a history of obstructive arteriosclerosis (2) Patient undergoing dialysis (3) Patients with systolic blood pressure of 160 mmHg or more measured immediately before remote ischemic preconditioning (4) Patients participating in other clinical trials (5) Patients who are judged inappropriate for the research subject by the attending physician
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tadayoshi Ikegami
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Medicine and Clinical Science
Zip code
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL	0836-22-2248
Email	i-keruma@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tadayoshi Ikegami
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Medicine and Clinical Science
Zip code
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL	0836-22-2248
Homepage URL
Email	i-keruma@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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 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
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 06 Month 25 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 10 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 09 Month 10 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038859

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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