UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041278 |
|---|---|
| Receipt number | R000047144 |
| Scientific Title | Prognostic value of baroreflex sensitivity in patients with atrial and ventricular arrhythmia. |
| Date of disclosure of the study information | 2020/08/02 |
| Last modified on | 2024/01/04 12:47:57 |
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Basic information
Public title
Prognostic value of baroreflex sensitivity in patients with atrial and ventricular arrhythmia.
Acronym
Association of BRS with Arrhythmia.
Scientific Title
Prognostic value of baroreflex sensitivity in patients with atrial and ventricular arrhythmia.
Scientific Title:Acronym
Association of BRS with Arrhythmia.
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prognostic value of baroreflex sensitivity in patients with atrial fibrillation.
Basic objectives2
Others
Basic objectives -Others
To investigate the prognostic value of baroreflex sensitivity in patients with atrial fibrillation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of atrial fibrillation, Hospitalization due to heart failure, Stroke, Cardiovasculat death
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are going to undergo catheter ablation for atrial fibrillation.
Key exclusion criteria
uncontrollable heart failure
uncontrollable hypertension
severe dysfunction of liver and kidney, cerebrovascular disease
Allergy to phenylephrine
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naohiko |
| Middle name | |
| Last name | Takahashi |
Organization
Oita University
Division name
Faculty of Medicine
Zip code
879-5593
Address
1-1 idaigaoka Hasama-machi, Yufu, Oita
TEL
0975866166
takanao@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Miyoshi |
Organization
Oita University
Division name
Faculty of Medicine
Zip code
879-5593
Address
1-1 idaigaoka Hasama-machi, Yufu, Oita
TEL
0975866166
Homepage URL
h-miho@oita-u.ac.jp
Sponsor or person
Institute
Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University
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
Faculty of Medicine, Oita University
Address
1-1 idaigaoka Hasama-machi, Yufu, Oita
Tel
0975866166
hkondo@oita-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
| 2020 | Year | 08 | Month | 02 | 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Nothing to report
Management information
Registered date
| 2020 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047144
