UMIN-CTR Clinical Trial

Basic information
Public title	Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur:A randomized open-labeled parallel controlled study
Acronym	Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur:A randomized open-labeled parallel controlled study
Scientific Title	Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur:A randomized open-labeled parallel controlled study
Scientific Title:Acronym	Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur:A randomized open-labeled parallel controlled study
Region	Japan

Condition
Condition	Acute exacerbation of chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical efficacy and safety of the early treatment with tolvaptan(V2receptor inhibiter)in hospitalized patients with acute exacerbation of chronic heart failure by comparing with the dose escalation treatment of loor diuretics.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Body weight change from baseline to day7
Key secondary outcomes	1 Average urine volumes of 3 days from day1 to day3 2 Differences of chest radiographic findings between baseline and day3,day7. 3 Changes of congestive heart failure symptoms from baseline : Dyspnea,JVD,Hepatic edema,Lower limb edema. 4 Changes of serum and urinary electrolyte concentration.; Na,K,Cl,Ca,Mg. 5 Changes of vital sign ; Blood pressure,Heart rate 6 Endocrine factors:Plasma renin activity,plasma aldosterone,urinary adorenalin,urinary noadorenalin,urinary dopamine 7 Serum creatinine 8 Loop Diuretics dose at discharge 9 Total amount of loop diuretic dose in the hospital 10 Occurrence of cardiovascular events and rehospitalization due to exacerbation of chronic heart failur in 6months after discharge 11 Adverse events in the hospital and 6months after discharge

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of 7.5mg to 15mg/day tolvaptan is started at the next day of admission and kept for 7 days, as an additional treatment to conventional therapy.The administration doses of any othre oral diuretics at admission are kept to discharge.
Interventions/Control_2	Doses of oral loop diuretics are increased in need from the next day of admission for 7 days.The administration doses of any other oral diuretics are kept from admission to discharge.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Patients with acute exacerbation of chronic heart failure. 2 Patients aged between 20 and 85 at giving the informed consent. 3 Patients who received loop diuretics (20mg/day or more of Frosemide,30mg/day or more of Azosemide,4mg/day or more of Torasemide.) 4 Patients with more than one of following congestive symptoms; dyspnea,pulmonary congestion,juglar venous distention,lower limb edema. 5 Patients who can receive drugs orally. 6 Patients with less than 3mg/dL of serum creatinine. 7 Patients who gave the infoemed consent to participate in the study of their own free will.
Key exclusion criteria	1 Patients with a history of hypersensitivity for an ingredient of tolvaptan or analogues such as Mozavaptan. 2 Patients with lowering consciousness. 3 Patients who need treatment with respirator. 4 Patients who receive artificial dialysis. 5 Patients with anuria. 6 Patients with severe liver disfunction. 7 Patients who cannot feel thirst or are difficult to intake the fluid. 8 Patients with hypernatremia. 9 Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant. 10 Patients otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Sueyoshi
Organization	UJI-TOKUSHUKAI MEDICAL CENTER
Division name	Cardiovascular Medicine
Zip code
Address	86 Kasugamori Ogura-cho Uji-city Kyoto, 611-0042 Japan
TEL	0774-20-1111
Email	rinri@ujitoku.or.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Sueyoshi
Organization	UJI-TOKUSHUKAI MEDICAL CENTER
Division name	Cardiovascular Medicine
Zip code
Address	86 Kasugamori Ogura-cho Uji-city Kyoto, 611-0042 Japan
TEL	0774-20-1111
Homepage URL
Email	rinri@ujitoku.or.jp

Sponsor
Institute	UJI-TOKUSHUKAI MEDICAL CENTER Cardiovascular Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Haibara General Hospital Cardiovascular Medicine
Name of secondary funder(s)	None

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 12 Month 27 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 12 Month 05 Day
Date of IRB	2013 Year 12 Month 11 Day
Anticipated trial start date	2013 Year 12 Month 26 Day
Last follow-up date	2016 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 12 Month 27 Day
Last modified on	2020 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014852