UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005669 |
|---|---|
| Receipt number | R000006708 |
| Scientific Title | Prospective cohort study for efficacy of peritoneal dialysis in the treatment of refractory congestive heart failure with chronic renal failure. |
| Date of disclosure of the study information | 2011/05/30 |
| Last modified on | 2011/05/30 15:18:02 |
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Basic information
Public title
Prospective cohort study for efficacy of peritoneal dialysis in the treatment of refractory congestive heart failure with chronic renal failure.
Acronym
The study for efficacy of peritoneal dialysis in the treatment of refractory congestive heart failure.
Scientific Title
Prospective cohort study for efficacy of peritoneal dialysis in the treatment of refractory congestive heart failure with chronic renal failure.
Scientific Title:Acronym
The study for efficacy of peritoneal dialysis in the treatment of refractory congestive heart failure.
Region
| Japan |
Condition
Condition
Refractory congestive heart failure, Chronic renal failure
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of peritoneal dialysis combined with conventional drug therapy on the cardiac function of patients with chronic heart failure and chronic renal failure (chronic kidney disease [CKD] stage 4-5).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chronic heart failure (New York Heart Association [NYHA]
Key secondary outcomes
Duration and frequency of hospitalization, Survival rate, and cardiac function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Peritoneal dialysis will be performed on the patients who choose this therapy in addition to the conventional treatment for chronic heart failure.
Interventions/Control_2
Conventional treatment for chronic heart failure.
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) age, ≥20 years; (2) severity of chronic heart failure, NYHA class 3 or 4; (3) renal function, CKD stage 4 or 5 and conformation to the Japanese criteria of Ministry of Health, Labour and Welfare (MHLW) for introduction of dialysis; and (4) written consent from the patient.
Key exclusion criteria
(1) patients for whom peritoneal dialysis is contraindicated on the basis of the information on the package insert; (2) women who are pregnant or possibly pregnant, or lactating women; and (3) patients judged by the attending physician as inappropriate for the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahito Tamura |
Organization
University of Occupational and Environmental Health University Hospital
Division name
Kidney Center
Zip code
Address
1-1 Iseigaoka, Yahata-Nishi Kitakyushu, Fukuoka Japan 807-8556
TEL
093-603-1611
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahito Tamura |
Organization
University of Occupational and Environmental Health University Hospital
Division name
Kidney Center
Zip code
Address
1-1 Iseigaoka, Yahata-Nishi Kitakyushu, Fukuoka Japan 807-8556
TEL
093-603-1611
Homepage URL
http://www.uoeh-u.ac.jp
mtamura@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health University Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health University Hospital
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
産業医科大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | 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
| 2011 | Year | 05 | Month | 30 | Day |
Last modified on
| 2011 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006708
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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