UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026331 |
|---|---|
| Receipt number | 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 13:37:01 |
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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
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
s1kitada@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Cardio-Renal Medicine and Hypertension, Graduate School of Medical Sciences, Nagoya City University, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030246
