UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009604 |
|---|---|
| Receipt number | R000011167 |
| Scientific Title | Assessment of QUAlity of life during long-term treatment of ToLVapatan in refractory heart failure.(AQUA-TLV) |
| Date of disclosure of the study information | 2012/12/21 |
| Last modified on | 2019/12/27 10:26:21 |
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Basic information
Public title
Assessment of QUAlity of life during long-term treatment of ToLVapatan in refractory heart failure.(AQUA-TLV)
Acronym
Assessment of QUAlity of life during long-term treatment of ToLVapatan in refractory heart failure.(AQUA-TLV)
Scientific Title
Assessment of QUAlity of life during long-term treatment of ToLVapatan in refractory heart failure.(AQUA-TLV)
Scientific Title:Acronym
Assessment of QUAlity of life during long-term treatment of ToLVapatan in refractory heart failure.(AQUA-TLV)
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess advantage in QOL for long administration of tolvaptan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL score (Minnesota Living With Heart Failure Questionnaire)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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 |
Interventions/Control_1
tolvaptan group
Interventions/Control_2
conventional treatment group
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) patients who was diagnosed with Frammingham criteria
2) in-hospital patients
3) patients who had a previous history of in-hospital treatment due to heart failure
4) NYHA III or IV
5) patients using over 60mg/day of fulosemide
6) patients with physical symptom due to heart failure
7) each gender is permitted
8) patients over 20 year old
9) patients able to consent
10) patients who consented himself
Key exclusion criteria
1) serum sodium concentration over 145mEq/L
2) patients who were administered tolvaptan before admission
3) patients who had received mechanical devices
4) patients with acute coronary syndrome
5) patients with future surgical procedure
6) patients with anuria
7) patients unable to drink
8) patients unable to take medicine orally
9) patients with urine osmolality under 350 mOsm/L
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Kinugawa |
Organization
University of Tokyo Hospital
Division name
Department of Therapeutic Strategy
Zip code
113 8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kinugawa-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Kinugawa |
Organization
University of Tokyo Hospital
Division name
Department of Therapeutic Strategy
Zip code
113 8655
Address
7-3-1, Hongo, bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
kinugawa-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku
Tel
03-3815-5411
crctky-office@umin.ac.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
| 2012 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/
Number of participants that the trial has enrolled
28
Results
Tolvaptan arm had significantly improved quality of life compared with the control arm
Results date posted
| 2019 | Year | 12 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
congestive heart failure patients
Participant flow
tolovaptan arm vs control arm
Adverse events
None
Outcome measures
quality of life at 6 months follow up
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 21 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011167
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