UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005157 |
|---|---|
| Receipt number | R000006124 |
| Scientific Title | Discharge Hemoglobin level and readmission in Patients with Chronic Heart Failure and Chronic Kidney Disease |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2017/08/05 22:25:48 |
* 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
Discharge Hemoglobin level and readmission in Patients with Chronic Heart Failure and Chronic Kidney Disease
Acronym
HF, CKD, anemia and readmission
Scientific Title
Discharge Hemoglobin level and readmission in Patients with Chronic Heart Failure and Chronic Kidney Disease
Scientific Title:Acronym
HF, CKD, anemia and readmission
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of hemoglobin level on early readmission in patients with heart failure and chronic kidney disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of early readmission due to heart failure
Key secondary outcomes
Base
Study type
Observational
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
eGFR <60 ml/min
admission due to heart failure
Key exclusion criteria
On dialysis therapy
Intestinal bleeding
Blood transfusion
Nephrotic syndrome
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Fukuma |
Organization
Kyoto University
Division name
Department of epidemiology and healthcare research
Zip code
Address
Yoshida Konoe-Cho, Sakyou-ku, Kyoto
TEL
075-753-4646
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Cardio-renal-anemia Project
Division name
Department of epidemiology and healthcare research, Kyoto university
Zip code
Address
Yoshida Konoe-Cho, Sakyou-ku, Kyoto
TEL
075-753-4646
Homepage URL
Sponsor or person
Institute
Department of epidemiology and healthcare research, Kyoto university
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conducted cohort study to clarify association between discharge hemoglobin level and early readmission in HF with CKD.
Management information
Registered date
| 2011 | Year | 02 | Month | 28 | Day |
Last modified on
| 2017 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006124
