UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of referral system for the management of heart failure with tolvaptan
Acronym	Referral system for heart failure with tolvaptan
Scientific Title	Effectiveness of referral system for the management of heart failure with tolvaptan
Scientific Title:Acronym	Referral system for heart failure with tolvaptan
Region	Japan

Condition
Condition	congestive heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of the referral system for the management of diuretics-resistant congestive heart failure with tolvaptan
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Scale of signs, symptoms, and parameters of congestion at 6 months after the administration of tolvaptan
Key secondary outcomes	all-cause mortality, cardiovascular mortality, re-admission for heart failure, and chenges in kidney function

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Other
Interventions/Control_1	Referral for the initiation of tolvaptan from clinic to hospital
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with congestive heart failure, refractory to the treatment with conventional diuretics
Key exclusion criteria	1. Petients with history of the adverse effects of tolvaptan 2. Patients on dialysis 3. Pregnant women, women who may be pregnant, and breast-feeding women 4. Patients with serum sodium over 145 mEq/L 5. Patients who cannot take medicine orally
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Watarai
Organization	Anjo Kosei Hospital
Division name	Cardiovascular Center
Zip code	446-8602
Address	28, Higashi-hirokute, Anjo-cho, Anjo City, Aichi
TEL	0566-75-2111
Email	junnai@kosei.anjo.aichi.jp

Public contact
Name of contact person	1st name Uemura Middle name Last name Yusuke
Organization	Anjo Kosei Hospital
Division name	Cardiovascular Center
Zip code	446-8602
Address	28, Higashi-hirokute, Anjo-cho, Anjo City, Aichi
TEL	0566-75-2111
Homepage URL
Email	yusuke0307@hotmail.com

Sponsor
Institute	Cardiovascular Center, Anjo Kosei Hospital
Institute
Department

Funding Source
Organization	none
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	Anjo Kosei Hospital
Address	28, Higashi-Hirokute, Anjo-cho, Anjo, JAPAN
Tel	0566-75-2111
Email	junnai@kosei.anjo.aichi.jp

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	2015 Year 11 Month 09 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	Completed
Date of protocol fixation	2015 Year 09 Month 15 Day
Date of IRB	2015 Year 09 Month 15 Day
Anticipated trial start date	2015 Year 09 Month 15 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 07 Day
Last modified on	2021 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022736