UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019675 |
|---|---|
| Receipt number | R000022736 |
| Scientific Title | Effectiveness of referral system for the management of heart failure with tolvaptan |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2021/11/11 15:43:40 |
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Basic information
Public title
Effectiveness of referral system for the management of heart failure with tolvaptan
Acronym
Referral system for heart failure with tolvaptan
Scientific Title
Effectiveness of referral system for the management of heart failure with tolvaptan
Scientific Title:Acronym
Referral system for heart failure with tolvaptan
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the referral system for the management of diuretics-resistant congestive heart failure with tolvaptan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scale of signs, symptoms, and parameters of congestion at 6 months after the administration of tolvaptan
Key secondary outcomes
all-cause mortality, cardiovascular mortality, re-admission for heart failure, and chenges in kidney function
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
| Medicine | Other |
Interventions/Control_1
Referral for the initiation of tolvaptan from clinic to hospital
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with congestive heart failure, refractory to the treatment with conventional diuretics
Key exclusion criteria
1. Petients with history of the adverse effects of tolvaptan
2. Patients on dialysis
3. Pregnant women, women who may be pregnant, and breast-feeding women
4. Patients with serum sodium over 145 mEq/L
5. Patients who cannot take medicine orally
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Watarai |
Organization
Anjo Kosei Hospital
Division name
Cardiovascular Center
Zip code
446-8602
Address
28, Higashi-hirokute, Anjo-cho, Anjo City, Aichi
TEL
0566-75-2111
junnai@kosei.anjo.aichi.jp
Public contact
Name of contact person
| 1st name | Uemura |
| Middle name | |
| Last name | Yusuke |
Organization
Anjo Kosei Hospital
Division name
Cardiovascular Center
Zip code
446-8602
Address
28, Higashi-hirokute, Anjo-cho, Anjo City, Aichi
TEL
0566-75-2111
Homepage URL
yusuke0307@hotmail.com
Sponsor or person
Institute
Cardiovascular Center, Anjo Kosei Hospital
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
Anjo Kosei Hospital
Address
28, Higashi-Hirokute, Anjo-cho, Anjo, JAPAN
Tel
0566-75-2111
junnai@kosei.anjo.aichi.jp
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
| 2015 | Year | 11 | Month | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 07 | Day |
Last modified on
| 2021 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022736
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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