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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033577
Receipt No. 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 2018/07/31

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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
Middle name
Last name Niinami Hiroshi
Organization Tokyo Women's Medical University
Division name Department of Cardiovascular Surgery
Zip code
Address 8-1 kawada-cho, Shinjuku-ku, Tokyo
TEL +81333538111
Email hniinami@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Domoto Satoru
Organization Tokyo Women's Medical University
Division name Department of Cardiovascular Surgery
Zip code
Address 8-1 kawada-cho, Shinjuku-ku, Tokyo
TEL +81333538111
Homepage URL
Email domoto.satoru@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
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

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
Anticipated trial start date
2018 Year 07 Month 31 Day
Last follow-up date
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
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038253

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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