UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052277 |
|---|---|
| Receipt number | R000059666 |
| Scientific Title | Prospective observational study of the age-dependent expression of signaling molecules responsive to angiotensin II in the human heart |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/11/11 14:01:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of the method to choose regimens to treat pediatric heart failure in an age-dependent manner
Acronym
Age-dependent treatment of pediatric heart failure
Scientific Title
Prospective observational study of the age-dependent expression of signaling molecules responsive to angiotensin II in the human heart
Scientific Title:Acronym
Analysis of the age-dependent response of the heart to angiotensin II
Region
| Japan |
Condition
Condition
Pediatric heart failure
Classification by specialty
| Cardiology | Pediatrics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop age-dependent treatment of pediatric heart failure utilizing type I angiotensin receptors by analyzing the age-dependent expression of signaling molecules responsive to angiotensin II in the human heart
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of the age-dependent expression of signaling molecules responsive to angiotensin II in the myocardium at a protein level
Key secondary outcomes
Analysis of the age-dependent expression of signaling molecules responsive to angiotensin II in the myocardium at an mRNA level
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
| 1 | days-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Inpatients
2. Patients going through open heart surgery due to any diseases
Key exclusion criteria
1. Patients under treatment of renin-angiotensin system inhibitors including type I angiotensin receptor blockers, angiotensin converting enzyme inhibitors, direct renin inhibitors, and ARNIs.
2. Patients infected with type B and C hepatitis virus or HIV.
3. Patients determined not adequate to be involved in this study by the lead principal investigator.
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiko |
| Middle name | |
| Last name | Yamada |
Organization
Shinshu University School of Medicine
Division name
Cevelopmental Pharmacology Study Group
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2058
myamada@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiko |
| Middle name | |
| Last name | Yamada |
Organization
Shinshu University School of Medicine
Division name
Developmental Pharmacology Study Group
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2058
Homepage URL
https://www.pediatheart.org/
myamada@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Mitsuhiko Yamada
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aichi Children's Health and Medical Center
Osaka Medical and Pharmaceutical University
Osaka City General Hospital
Kanazawa Medical University
Fifu Prefectural General Medical Center
Kyushu University
Kyoto University
Gunma Children's Medical Center
Keio University
Kobe University
Saitama Prefectural Children's Medical Center
Shizuoka Children's Hospital
Jichi Medical University
Shimane University
Juntendo University
Chiba Children's Hospital
The Jikei University School of Medicine
Tokyo Metropolitan Children's Medical Center
University of Toyama
Nagano Children's Hospital
Nippon Medical School Foundation
Hiroshima City Hiroshima Citizens Hospital
Hokkaido University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621 Japan
Tel
0263-37-2572
mdrinri@shinshu-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
あいち小児保健医療総合センター
大阪医科薬科大学
大阪市立総合医療センター
金沢医科大学
岐阜県総合医療センター
九州大学
京都大学
群馬県立小児医療センター
慶應義塾大学
神戸大学
埼玉県立小児医療センター
静岡県立こども病院
自治医科大学
島根大学
順天堂大学
千葉県こども病院
東京慈恵会医科大学
東京都立小児総合医療センター
富山大学
長野県立こども病院
日本医科大学
広島市民病院
北海道大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationship between age and the expression of signaling molecules responsive to angiotensin II in the human heart
Management information
Registered date
| 2023 | Year | 09 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059666
