UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Tolvaptan in heart failure patients with preserved Ejection fraction: multicenter, RaNdomized, open-label triAL (ETERNAL)
Title of the study (Brief title)	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	Toyoaki Murohara
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Cardiology
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2147
Email	eternal-nagoya@gmail.com

Public contact
Name of contact person	Takahiro Okumura
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 05 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012377