UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034523 |
|---|---|
| Receipt number | R000039359 |
| Scientific Title | Evaluation of the association between %proBNP at admission and change of cardiac function after discharge in patients with acute heart failure |
| Date of disclosure of the study information | 2018/10/18 |
| Last modified on | 2024/05/01 14:40:51 |
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Basic information
Public title
Evaluation of the association between %proBNP at admission and change of cardiac function after discharge in patients with acute heart failure
Acronym
ProBNP study
Scientific Title
Evaluation of the association between %proBNP at admission and change of cardiac function after discharge in patients with acute heart failure
Scientific Title:Acronym
ProBNP study
Region
| Japan |
Condition
Condition
Acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between %proBNP at admission and change of cardiac function after discharge in patients with acute heart failure
Basic objectives2
Others
Basic objectives -Others
To evaluaste the association of %proBNP and clinical outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association between %proBNP at admission and changes of cardiac function during 6 months after discharge in patients with acute heart failure.
Key secondary outcomes
1) The association between %proBNP at admission and change of EF with echocardiography in patients of acute heart failure with preserved ejection fraction 6 months after discharge
2) The association between %proBNP at admission and change of left ventricular end-diastolic dimension (LVDd)
3) The association between Cyclic GMP/BNP at admission and change of EF with echocardiography 6 months after discharge
4) The association between ProANP, ANP and change of EF with echocardiography 6 months after discharge
5) The association between %proBNP and Neprilysin at admission/discharge
6) The association of %proBNP and composite outcomes (all-cause death and readmission for heart failure)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patients who required hospitalization due to heart failure treatments.
2) The patients who will be admitted to our hospital for acute heart failure within 48 hours
3) The patients who will consent to participation with written forms
Key exclusion criteria
1) The patients who undergo dialysis
2) The patients who have been treated with Carperitide before blood sampling
3) acute coronary syndromes
4) The patients who will be considered inappropriate for participation for other reasons
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Izumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
5648565
Address
5-7-1, Fujishirodai, Suita
TEL
06-6833-5012
izumi-ch@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Takahashi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
5-7-1, Fujishirodai, Suita
TEL
06-6833-5012
Homepage URL
takahashi.kanako@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, SPorts and Science and Technology
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
Research Ethics Committee
Address
SUita
Tel
06-6170-1069
ncvc@esct.bvits.com
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 | 10 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039359
