UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open-label, prospective randomized trial to assess the non-inferiority of diuretic effect of tolvaptan as an alternative agent to loop diuretics in chronic heart failure.
Title of the study (Brief title)	The effectiveness of tolvaptan as an alternative agent to loop diuretics in heart failure.
Region	Japan

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

Objectives
Narrative objectives1	This study is to assess the non-inferiority of diuretic effect of tolvaptan as an alternative therapy to loop diuretics in heart failure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in BNP levels from the enrolment in this trial to 2 months later.
Key secondary outcomes	1) Changes in renal functional parameters: creatinine clearance, urinary microalbumin excretion, and urinary L-FABP excretion, from the enrolment in this trial to 2 months later. 2) Adverse events which are defined as all cause death, worsening of heart failure requiring an increase in an amount of loop diuretics, and ventricular arrhythmia which need cardioversion or defibrillation, during the period from the enrolment in this trial to 2 months later. 3) Adverse events which are defined as cardiovascular death and/or hospitalization for heart failure during 6 months after 2 months intervention period.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intervention group: Patients in whom furosemide of 20 mg was partly replaced by tolvaptan of 3.75 or 7.5 mg a day as an alternative in patients with heart failure receiving furosemide more than 40 mg a day. Intervention period is 2 months.
Interventions/Control_2	Control group: Patients with heart failure who continue to receive furosemide of more than 40 mg a day.
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	Patients who are older than 20 years and have been receiving loop diuretics of the amount equivalent to more than 40 mg a day of furosemide due to chronic heart failure. The patients with in stable condition without changes in both symptoms and therapy of heart failure within one month prior to the enrolment.
Key exclusion criteria	1. Patients who have already received tolvaptan therapy. Patients who are more than 80 years and have difficulty in complain thirst. 2. Patients with renal dysfunction having an estimated glomerular filtration rate 30mL or less /min/1.73m2 and/or requiring hemodialysis. 3. Patients with liver dysfunction which is defined as an increase threefold in aspartate aminotransferase and/or alanine aminotransferase compared to the upper limit of normal range. 4. Patients with percutaneous coronary intervention or open heart surgery within the past 3 months. 5. Patients under the pacing therapy using implantable cardiac pacemaker, cardiac resynchronization therapy device, or implantable cardiac defibrillator. 6. Patients with type 1 diabetes mellitus. 7. Patients with endocrine diseases such as thyroid dysfunction, or adrenal dysfunction which may have an effect on balance of body fluid. 8. Patients with any serious non-cardiovascular disease including malignancy, which have expected 6 months or less to live. 9. Patients without agreement on enrolment of this trial through written texts.
Target sample size	200

Research contact person
Name of lead principal investigator	Shuichi Kitada
Organization	Nagoya City University, Japan
Division name	Department of Cardio-Renal Medicine and Hypertension
Address	1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
TEL	052-853-8221
Email	s1kitada@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Shuichi Kitada
Organization	Nagoya City University, Japan
Division name	Department of Cardio-Renal Medicine and Hypertension
Address	1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
TEL	052-853-8221
Homepage URL
Email	s1kitada@med.nagoya-cu.ac.jp

Sponsor
Institute	Department of Cardio-Renal Medicine and Hypertension, Graduate School of Medical Sciences, Nagoya City University, Japan
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	名古屋市立大学病院（愛知県） Nagoya City University Hospital, Aichi, Japan

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 16 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2020 Year 02 Month 28 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Related information
URL releasing protocol	http://www.med.nagoya-cu.ac.jp/cr.dir/patient/f_patient.html
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 28 Day
Last modified on	2017 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030246