UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034087
Receipt number R000038859
Scientific Title Study on fluctuation of kidney biomarker at chronic heart failure patients given by remote ischemic preconditioning
Date of disclosure of the study information 2018/09/10
Last modified on 2018/09/10 23:21:36

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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