![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000034087 |
Receipt No. | 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 |
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 |
|
Condition | ||
Condition | patients with chronic heart failure | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
i-keruma@yamaguchi-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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 | |||||||
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |