UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011012 |
|---|---|
| Receipt number | R000012377 |
| Scientific Title | Efficacy of Tolvaptan in heart failure patients with preserved Ejection fraction: multicenter, RaNdomized, open-label triAL (ETERNAL) |
| Date of disclosure of the study information | 2013/06/25 |
| Last modified on | 2018/12/26 18:09:57 |
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Basic information
Public title
Efficacy of Tolvaptan in heart failure patients with preserved Ejection fraction: multicenter, RaNdomized, open-label triAL (ETERNAL)
Acronym
ETERNAL
Scientific Title
Efficacy of Tolvaptan in heart failure patients with preserved Ejection fraction: multicenter, RaNdomized, open-label triAL (ETERNAL)
Scientific Title:Acronym
ETERNAL
Region
| Japan |
Condition
Condition
Heart Failure with Preserved Ejection Fraction (HFPEF)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of tolvaptan in heart failure patients with preserved ejection fraction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in renal function (serum creatinine level, estimated GFR)
Change in serum sodium level
Change in plasma BNP level
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
Additional tolvaptan therapy
Interventions/Control_2
Conventional therapy only
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) Heart failure patients diagnosed by Framingham criteria
2) patients with refractory fluid retention in spite of loop-diuretic therapy (>20mg frosemide doses)
3) Preserved ejection fraction (LVEF >45%)
4) patients who had a previous history of in-hospital treatment due to heart failure in the past year
5) In-hospital patients at the entry
6) Informed consent by document was obtained
Key exclusion criteria
1) Hypernatremia (serum Na >145mEq/L)
2) patients who already have tolvaptan at the entry
3) Insensitivity to the thirst or difficult for the water intake
4) Anuria
5) Hepatic disease
6) Pregnant or possibly pregnant
7) A history of hypersensitivity to tolvaptan
8) Severe valvular heart diseases with significant regurgitation and/or stenosis, pulmonary disease
9) Constrictive pericarditis
10) Malignancy
11) Scheduled surgical procedure
12) Any conditions inappropriate to this trial by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoaki Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2147
eternal-nagoya@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Okumura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2147
Homepage URL
eternal-nagoya@gmail.com
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 25 | 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
| 2013 | Year | 06 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012377
