UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056429 |
|---|---|
| Receipt number | R000064455 |
| Scientific Title | Single-center prospective observational study to evaluate the relationship between the anti-heart failure effects of Sacubitril/Valsartan and genetic polymorphisms. |
| Date of disclosure of the study information | 2024/12/11 |
| Last modified on | 2024/12/11 19:04:23 |
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Basic information
Public title
Single-center prospective observational study to evaluate the relationship between the anti-heart failure effects of Sacubitril/Valsartan and genetic polymorphisms.
Acronym
Genomic pharmacology research on ARNI.
Scientific Title
Single-center prospective observational study to evaluate the relationship between the anti-heart failure effects of Sacubitril/Valsartan and genetic polymorphisms.
Scientific Title:Acronym
Genomic pharmacology research on ARNI.
Region
| Japan |
Condition
Condition
Chronic heart failure
Acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the relationship between clinical efficacy and genetic polymorphisms in heart failure patients treated with Sacubitril/Valsartan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hospitalization due to exacerbation of heart failure
Cardiovascular events
heart disease-related death
Key secondary outcomes
NT-proBNP
BNP
sST2
All-cause death
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
Patients who are 20 years of age or older at the time of consent.
Patients with heart failure symptoms of NYHA classification II or higher.
Patients newly introduced to Sacubitril/Valsartan as treatment for heart failure.
Patients who have been fully informed of the study and who have given written consent of their own free will.
Key exclusion criteria
Patients with significantly poor medication adherence
Patients with advanced cancer
Patients with a history of autoimmune disease.
Patients with severe hepatic dysfunction. (Total bilirubin 2 mg/dl or more)
Patients with severe renal dysfunction. (Creatine 2 mg/dl or more)
Patients deemed inappropriate by the attending physician, etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kawakami |
Organization
Hamamatsu University School of Medicine
Division name
Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2767
kojisuzu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Hospital Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2767
Homepage URL
kojisuzu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Life Science and Medical Research, Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2680
rinri@hama-med.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
| 2024 | Year | 12 | Month | 11 | 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
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
Single-center prospective observational study
Inclusion Criteria
Patients with heart failure symptoms of NYHA Class II or higher and newly induction of Sacubitril/Valsartan
Exclusion criteria
Patients with significantly poor medication adherence
Patients with advanced cancer
Patients with a history of autoimmune disease.
Patients with severe hepatic dysfunction. (Total bilirubin 2 mg/dl or more)
Patients with severe renal dysfunction. (Creatine 2 mg/dl or more)
Patients deemed inappropriate by the attending physician, etc.
Main endpoints of the observational study
Presence of related genetic polymorphisms
Comparison of heart failure events (unscheduled visits, hospitalizations) among the stratified clusters
Comparison of improvement in heart failure markers (NT-proBNP)
Management information
Registered date
| 2024 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064455
