UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057029 |
|---|---|
| Receipt number | R000065185 |
| Scientific Title | Examination of optimal patient endpoints in developing new therapeutic drugs for symptomatic bradycardia. |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2026/02/09 20:25:39 |
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Basic information
Public title
Examination of optimal patient endpoints in developing new therapeutic drugs for symptomatic bradycardia.
Acronym
Examination of optimal patient endpoints in developing new therapeutic drugs for symptomatic bradycardia.
Scientific Title
Examination of optimal patient endpoints in developing new therapeutic drugs for symptomatic bradycardia.
Scientific Title:Acronym
Examination of optimal patient endpoints in developing new therapeutic drugs for symptomatic bradycardia.
Region
| Japan |
Condition
Condition
bradyarrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate quality of life before and after novel pacemaker implantation treatment for symptomatic bradyarrhythmia using multiple quality of life assessment indices with established evidence for heart failure.
Basic objectives2
Others
Basic objectives -Others
The various symptoms of symptomatic bradyarrhythmia, the diversity of patient backgrounds such as age and disease, and the variability of various QOL indices will be extracted, leading to the creation of optimal QOL evaluation indices for a population of patients who are expected to be included in future clinical trials for symptomatic bradyarrhythmias.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in various quality of life indices before and after pacemaker implantation.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who provided written informed consent for study participation of their own free will.
2) Patients aged 18 years or older but under 80 years at the time of consent acquisition.
3) Patients with any of the following bradyarrhythmias:
Sinus node dysfunction: Type I, Type II.
Atrioventricular block: First degree, Second degree or high-grade, and Third degree.
Bradyarrhythmic atrial fibrillation.
4) Patients with any of the following symptoms caused by bradyarrhythmia:
Fatigue, shortness of breath, decreased exercise tolerance, dizziness, lightheadedness, syncope, falls,
dyspnea, chest pain, nausea, psychological burden due to the above symptoms.
Key exclusion criteria
1) Patients with the following conditions or a history thereof:
Moderate or severe aortic valve or mitral valve disease.
Thyroid dysfunction.
Ischemic heart disease (including myocardial infarction).
Myocardial diseases such as cardiomyopathy.
Patients with currently active malignant tumors or those who completed treatment for malignant tumors less than 5 years ago.
2) Patients with active infections requiring systemic treatment.
3) Patients with psychiatric disorders that pose problems for follow-up or compliance with the study protocol.
4) Other patients deemed inappropriate by the principal investigator or sub-investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Asano |
Organization
National Cerebral and Cardiovascular Center
Division name
Genome Medicine Support Department
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita City, Osaka, Japan
TEL
06-6170-1070
asano.yoshihiro@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Asano |
Organization
National Cerebral and Cardiovascular Center
Division name
Genome Medicine Support Department
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita City, Osaka, Japan
TEL
06-6170-1070
Homepage URL
asano.yoshihiro@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agent for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital Ethics Application Committee
Address
2-2 Yamadaoka, Suita City, Osaka, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2025 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NONE
Management information
Registered date
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065185
