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

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 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


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

Value
https://center6.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