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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011012
Receipt No. 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

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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
Email 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
Email eternal-nagoya@gmail.com

Sponsor
Institute Nagoya University Graduate School of Medicine, Department of Cardiology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012377

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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