UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000009604
Receipt No. 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 (Ver. 8)

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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
Email 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
Email kinugawa-tky@umin.ac.jp

Sponsor
Institute University of Tokyo Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011167