UMIN-CTR Clinical Trial

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
Email	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
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	Tokyo Women's Medical University
Address	8-1 kawada-cho, Shinjuku-ku, Tokyo
Tel	+81333538111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038253