UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008258 |
|---|---|
| Receipt number | R000009729 |
| Scientific Title | Multicenter Tolvaptan study For Uncontrolled volume overload in Japanese acute decompensated heart failure patients: A prospective observational multicenter cohort study |
| Date of disclosure of the study information | 2012/06/26 |
| Last modified on | 2016/12/29 09:06:25 |
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Basic information
Public title
Multicenter Tolvaptan study For Uncontrolled volume overload in Japanese acute decompensated heart failure patients: A prospective observational multicenter cohort study
Acronym
MT FUJI study
Scientific Title
Multicenter Tolvaptan study For Uncontrolled volume overload in Japanese acute decompensated heart failure patients: A prospective observational multicenter cohort study
Scientific Title:Acronym
MT FUJI study
Region
| Japan |
Condition
Condition
Hospitalized and decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of the present study are to investigate prospectively the clinical course and outcome of the hospitalized heart failure patients treated with tolvaptan for managements of fluid retention and serum sodium levels of less than 140 mEq/L and also to analyze the factors related with the efficacy including outcome of tolvaptan therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
Safety: adverse events
long-term outcome (1year after tolvaptan administration)
Key secondary outcomes
Search for the factors related with the efficacy of tolvaptan therapy and long-term outcome
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) hospitalized patients for decompensated heart failure with signes of fluid retention and planned tolvaptan use
2) serum Na < 140 mEq/L
3) age: > or = 20 years at the time of informed consent
4) the subject is willing to participate in the study
Key exclusion criteria
1)hemodynamic instability
2)patients with hypersensitivity to study drug or similar compounds
3)anuric patients
4)patients who cannot feel thirst and are difficult to intake the fluid
5)patients are willing to pregnant, potentially pregnant women, pregnant
6)patients have taken tolvaptan
7)acute coronary syndrome
8)adrenal insufficiency
9)scheduled patients underwent coronary angioplasty within the study period
10)the patient regarded as inappropriate for this clinical study by the principal investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Sato |
Organization
Nippon Medical School Musashi-Kosugi Hospital
Division name
Department of Cardiology
Zip code
Address
1-396 Kosugi Nakahara-ku Kawasaki-shi Knakagawa, Japan
TEL
044-733-5181
nms-ns@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Sato |
Organization
Nippon Medical School Musashi-Kosugi Hospital
Division name
Department of Cardiology
Zip code
Address
1-396 Kosugi Nakahara-ku Kawasaki-shi Knakagawa, Japan
TEL
044-733-5181
Homepage URL
nms-ns@nms.ac.jp
Sponsor or person
Institute
MT FUJI study steering committee
Institute
Department
Personal name
Funding Source
Organization
Fundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
MT FUJI study group
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
The following endpoints shall be evaluated.
Efficacy and safty
1) Alleviation of the signs of body fluid retention by the 7th day of treatment with tolvaptan (or the day of discontinuation of the drug in cases where tolvaptan treatment has been discontinued before the 7th day) as compared with the observations made on the day before the start of treatment
2) Change of the serum sodium level by the 7th day of treatment with tolvaptan as compared with the level measured on the day before the start of treatment
3) Changes in the daily urinary volume, serum potassium level, renal function parameters (serum creatinine level, BUN) and neurohumoral factors by the 7th day of treatment with tolvaptan as compared with the corresponding values measured on the day before the start of treatment
4) Adverse events until 30 days after the end of treatment with tolvaptan
Outcome
1) Cardiovascular events within 1 year after administration of tolvaptan
2)Number of days until, and frequency of, re-hospitalization for aggravation of heart failure within 1 year after administration of tolvaptan
3)Number of days until all-cause death after administration of tolvaptan
exploratory analysis
1)related factors regarding efficacy of tolvaptan
2)related factors regarding long-term outcome
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2016 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009729
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