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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026331
Receipt No. R000030246
Scientific Title 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.
Date of disclosure of the study information 2017/03/01
Last modified on 2017/02/28

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Basic information
Public title 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.
Acronym The effectiveness of tolvaptan as an alternative agent to loop diuretics in heart failure.
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Shuichi Kitada
Organization Nagoya City University, Japan
Division name Department of Cardio-Renal Medicine and Hypertension
Zip code
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
1st name
Middle name
Last name Shuichi Kitada
Organization Nagoya City University, Japan
Division name Department of Cardio-Renal Medicine and Hypertension
Zip code
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

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 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

Related information
URL releasing protocol http://www.med.nagoya-cu.ac.jp/cr.dir/patient/f_patient.html
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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 16 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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