UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034148 |
|---|---|
| Receipt number | R000038927 |
| Scientific Title | Clinical Study on Responder Prediction in Cardiac Resynchronization Therapy Using Individual Molecular Measurement of Natriuretic Peptide |
| Date of disclosure of the study information | 2018/09/14 |
| Last modified on | 2025/03/24 10:20:19 |
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Basic information
Public title
Clinical Study on Responder Prediction in Cardiac Resynchronization Therapy Using Individual Molecular Measurement of Natriuretic Peptide
Acronym
Clinical Study on Responder Prediction in Cardiac Resynchronization Therapy Using Individual Molecular Measurement of Natriuretic Peptide
Scientific Title
Clinical Study on Responder Prediction in Cardiac Resynchronization Therapy Using Individual Molecular Measurement of Natriuretic Peptide
Scientific Title:Acronym
Clinical Study on Responder Prediction in Cardiac Resynchronization Therapy Using Individual Molecular Measurement of Natriuretic Peptide
Region
| Japan |
Condition
Condition
Patients with cardiac resynchronization therapy (CRT)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the efficacy of each natriuretic peptide concentration or ratio for predicting CRT responder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Deaths from any cause and heart failure admissions
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients planning to implant CRT at our hospital and have serum creatinine level less than 1.5 mg/dl
Key exclusion criteria
Patients with serum creatinine level equal or over 1.5 mg/dl, dialysis, and who judged to be ineligible for participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Yasuda |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
yasuda.satoshi.hp@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
Homepage URL
kusanokengo@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
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
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 | 09 | Month | 14 | 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
| 2013 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the relationship between natriuretic peptide concentration or ratio and the responder of cardiac resynchronization therapy (CRT)
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038927
