UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049990 |
|---|---|
| Receipt number | R000056930 |
| Scientific Title | Evaluation of heart failure pathophysiology targeting cardiac cyclic GMP |
| Date of disclosure of the study information | 2023/01/12 |
| Last modified on | 2023/01/08 11:59:27 |
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Basic information
Public title
Evaluation of heart failure pathophysiology targeting cardiac cyclic GMP
Acronym
Investigation for cardiac derived cyclic GMP in patients with heart failure
Scientific Title
Evaluation of heart failure pathophysiology targeting cardiac cyclic GMP
Scientific Title:Acronym
Investigation for cardiac derived cyclic GMP in patients with heart failure
Region
| Japan |
Condition
Condition
Patients with heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze association of clinical background and natriuretic peptide with cardiac-derived cyclic GMP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart failure treatment responsiveness as changes of plasma BNP levels
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with heart failure who will undergo right heart catetherizaion
2) patients with heart failure (Stage C and D)
Key exclusion criteria
1) Patients who are receiving intravenous administration of carperitide or nitrate, or those who received them within 24 hours from the gaining the consent.
2) Patients who are receiving dialysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takahama |
Organization
Tohoku university hospital
Division name
Department of cardiovascular medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7153
takahama@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takahama |
Organization
Tohoku university hospital
Division name
Department of cardiovascular medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7153
Homepage URL
takahama@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 01 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 01 | Month | 08 | Day |
Last modified on
| 2023 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056930
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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