UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033577 |
|---|---|
| Receipt number | R000038253 |
| Scientific Title | Efficacy and safety of tolvaptan in patients with severe aortic stenosis and chronic kidney disease undergoing transcatheter aortic valve replacement |
| Date of disclosure of the study information | 2018/07/31 |
| Last modified on | 2021/02/01 13:58:24 |
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Basic information
Public title
Efficacy and safety of tolvaptan in patients with severe aortic stenosis and chronic kidney disease undergoing transcatheter aortic valve replacement
Acronym
TOlvaptan in Patients with severe aortic Stenosis undergoing Transcatheter Aortic valve Replacement
(TOPSTAR)
Scientific Title
Efficacy and safety of tolvaptan in patients with severe aortic stenosis and chronic kidney disease undergoing transcatheter aortic valve replacement
Scientific Title:Acronym
TOlvaptan in Patients with severe aortic Stenosis undergoing Transcatheter Aortic valve Replacement
(TOPSTAR)
Region
| Japan |
Condition
Condition
aortic valve stenosis, chronic kidney disease
Classification by specialty
| Cardiology | Nephrology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of effects of furosemide and tolvaptan on renal function in patients with aortic valve stenosis complicated with chronic kidney disease undergoing transcatheter aortic valve replacement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in renal function before and one month after treatment
Key secondary outcomes
Changes before and one month after treatment of the following items
1 weight
2 blood pressure
3 urine volume, urine osmotic pressure
4 serum electrolyte
5 Serum osmotic pressure
6 nerve fluid factor
7 Presence or absence of atrial fibrillation
8 echocardiographic findings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After qualification, the subjects are assigned 1: 1 ratio to the furosemide continuation group or tolvaptan administration group. Furosemide continuation group will continue the preoperative dose.
Interventions/Control_2
For tolvaptan administered group, substitution of furosemide 20 mg / day orally before TAVI surgery, with tolvaptan at 3.75 mg / day after surgery. In the case of furosemide 40 mg / day oral administration, administration was started by substituting tolvaptan 7.5 mg / day after surgery. Continue until outpatient visit one month after surgery.
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 satisfy all the following criteria are targeted.
1 Patient who is visiting or hospitalized for department of cardiovascular surgery or cardiology at Tokyo Women's Medical University Hospital
2 Patients diagnosed as severe aortic valve stenosis and judged to require TAVI treatment
3 Patients with complication of chronic kidney disease witheGFR <45 mL / min / 1.73 m 2 at the time of qualification confirmation
4 Patients who routinely use loop diuretics before TAVI surgery
Key exclusion criteria
Patients who violate the following criteria are excluded from this study
1 Patients receiving hemodialysis therapy
2 patients already taking tolvaptan
3 Patients with difficult oral medication
4 Patients who do not feel dry mouth
5 Those whose serum sodium level measured within 24 hours before the start of the study drug exceeds 150 mEq / ml
6 In addition, patients whose research managers judged inappropriate as subjects
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Niinami |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiovascular Surgery
Zip code
162-8666
Address
8-1 kawada-cho, Shinjuku-ku, Tokyo
TEL
+81333538111
hniinami@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Domoto |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiovascular Surgery
Zip code
162-8666
Address
8-1 kawada-cho, Shinjuku-ku, Tokyo
TEL
+81333538111
Homepage URL
domoto.satoru@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
Tokyo Women's Medical University
Address
8-1 kawada-cho, Shinjuku-ku, Tokyo
Tel
+81333538111
domoto.satoru@twmu.ac.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
| 2018 | Year | 07 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 31 | 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
| 2018 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038253
