UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031667 |
|---|---|
| Receipt number | R000036168 |
| Scientific Title | Clinical Safety and Effectiveness of Tolvaptan for patients with heart falure |
| Date of disclosure of the study information | 2018/03/11 |
| Last modified on | 2023/01/14 09:01:38 |
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Basic information
Public title
Clinical Safety and Effectiveness of Tolvaptan for patients with heart falure
Acronym
Clinical Safety and Effectiveness of Tolvaptan
Scientific Title
Clinical Safety and Effectiveness of Tolvaptan for patients with heart falure
Scientific Title:Acronym
Clinical Safety and Effectiveness of Tolvaptan
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of tolvaptan for heart failure patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical adverse events in-hospital, at 6 month follow-up, at 12 month follow-up, and at 24 month follow-up
(all-cause death, cardiovascular death, worsened heart failure, cerebral infarction, intubation, fetal arrhythmia, discharge postponement, rehospitalization)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
acute heart failure cases who admitted at Teikyo University hospital and had oral tolvaptan
Key exclusion criteria
none
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Kataoka |
| Middle name | |
| Last name | Akihisa |
Organization
Teikyo University
Division name
Department of Medicine
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
+81-3-3964-1211
kataoaki@sd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kataoka |
| Middle name | |
| Last name | Akihisa |
Organization
Teikyo University Hospital
Division name
Department of Medicine
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
+81-3-3964-1211
Homepage URL
kataoaki@sd5.so-net.ne.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University IRB
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
Tel
03-3964-7256(42203)
turb-office@teikyo-u.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 | 03 | Month | 11 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00380-021-01934-8?fbclid=IwAR3xITQKlaGde3kTcRVD7hpdzd6hSR
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00380-021-01934-8?fbclid=IwAR3xITQKlaGde3kTcRVD7hpdzd6hSR
Number of participants that the trial has enrolled
317
Results
After multiple adjustments, there were no significant differences for overall survival and rehospitalization between the groups.
Results date posted
| 2021 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients were divided into 2 groups: those who had significant FMR and those who did not at discharge.
Participant flow
This is a retrospective, single-center, observational study. Patients who were hospitalized due to congestive HF defined according to the Framingham criteria at our institution during two periods: between May 2011 and April 2012 (before TLV was approved) and between May 2017 and April 2018 (after TLV was approved) were enrolled in the study.
Adverse events
N/A
Outcome measures
Primary objective was to evaluate the efficacy of TLV to reduce the all-cause mortality and rehospitalization due to worsening HF in patients with significant FMR during one year of follow-up. Our secondary objective was to evaluate the same outcomes in patients without significant FMR.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: observation study
Study (enrolment) duration: Nov 2, 2019 to Mar 31, 2018
Object recruitment: acute heart failure cases who admitted at Teikyo University hospital and had oral tolvaptan
Observation item: Clinical adverse events in-hospital, at 6 month follow-up, at 12 month follow-up, and at 24 month follow-up
(all-cause death, cardiovascular death, worsened heart failure, cerebral infarction, intubation, fetal arrhythmia, discharge postponement, rehospitalization)
Management information
Registered date
| 2018 | Year | 03 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036168
