UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013807 |
|---|---|
| Receipt number | R000015336 |
| Scientific Title | Long-term Effect of Tolvaptan Administration for Outcome and Neurohormonal Factors in Patients with Heart Failure |
| Date of disclosure of the study information | 2014/04/25 |
| Last modified on | 2017/07/23 07:52:48 |
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Basic information
Public title
Long-term Effect of Tolvaptan Administration for Outcome and Neurohormonal Factors in Patients with Heart Failure
Acronym
Clinical Effect of Long-term Tolvaptan Administration
Scientific Title
Long-term Effect of Tolvaptan Administration for Outcome and Neurohormonal Factors in Patients with Heart Failure
Scientific Title:Acronym
Clinical Effect of Long-term Tolvaptan Administration
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinical effect of long-term Tolvaptan administration in patients with heart failure with fluid retention. Especially, to examine the effects of neurohormonal factors and renal function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in neurohormonal factors (catecholamine, renin activity, aldosterone, copeptin)
Key secondary outcomes
The finding of fluid retention, the changes in serum sodium, BUN, Cr, urinary L-FABP, dosage of diuretics, blood pressure, heart rate and 6-month prognosis (readmission and death)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Assigned following 2 groups, when heart failure treatment is hemodynamically stable.
TLV group: Add on tolvaptan (1.875mg/day to 15mg/day) with conventional diuretics for 6 months.
Interventions/Control_2
Conventinal diuretics group: Treat with conventional diuretics except tolvaptan for 6 months.
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
Heart failure in-hospital patients with fluid retention
Required continuous diuretics treatment
Key exclusion criteria
Patients with a history of hypersensitivity for tolvaptan or an analogue.
Anuresis or hypernatremia.
Patients who have difficulty with fluid intake or can not feel dipsesis.
Pregnant woman or possibility of the pregnancy.
Patients whom tolvaptan is already given at registration.
Patients whom study responsibility physician judged inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Iida |
Organization
Nihon University Surugadai Hospital
Division name
Department of Cardiology
Zip code
Address
1-8-13 Kanda-Surugadai, Chiyoda, Tokyo
TEL
03-3293-1711
kiida2830@jcom.home.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Iida |
Organization
Nihon University Surugadai Hospital
Division name
Department of Cardiology
Zip code
Address
1-8-13 Kanda-Surugadai, Chiyoda, Tokyo
TEL
03-3293-1711
Homepage URL
kiida2830@jcom.home.ne.jp
Sponsor or person
Institute
Nihon University Surugadai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
駿河台日本大学病院（東京都）、日本大学板橋病院（東京都）、聖路加国際病院（東京都）、三井記念病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 25 | 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
| 2014 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 20 | 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
| 2014 | Year | 04 | Month | 25 | Day |
Last modified on
| 2017 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015336
| 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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| Registered date | File name |
