UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044855 |
|---|---|
| Receipt number | R000051234 |
| Scientific Title | Underlying mechanisms associated with long-term prognosis between patients with new-onset heart failure and worsening of chronic hart failure |
| Date of disclosure of the study information | 2021/07/13 |
| Last modified on | 2022/02/04 20:16:32 |
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Basic information
Public title
Underlying mechanisms associated with long-term prognosis between patients with new-onset heart failure and worsening of chronic hart failure
Acronym
KINDAI-HF Registry
Scientific Title
Underlying mechanisms associated with long-term prognosis between patients with new-onset heart failure and worsening of chronic hart failure
Scientific Title:Acronym
KINDAI-HF Registry
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with worsening o chronic Heart failure have worse prognosis compared to those with new-onset heart failure. The aim of this prospective cohort study is to clarify difference of underlying mechanisms associated with prognosis between patients with new-onset heart failure and worsening of chronic heart failure.
Basic objectives2
Others
Basic objectives -Others
To clarify underlying mechanisms associated with prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of composite endpoint between patients with new-onset heart failure and worsening of chronic heart failure
Key secondary outcomes
Clinical factors associated with long-term prognosis between patients with new-onset heart failure and worsening of chronic 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized with acute heart failure
Key exclusion criteria
Not obtained informed consent
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | Koichiro |
| Last name | Matsumura |
Organization
Kindai University
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81723660221
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81723660221
Homepage URL
kmatsumura1980@yahoo.co.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
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
Department of Cardiology, Kindai University
Address
377-2, Ohnohigashi, Osakasayama
Tel
+81723660221
kmatsumura1980@yahoo.co.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
| 2021 | Year | 07 | Month | 13 | 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
| 2021 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:
Prospective cohort study
Participants:
Patients hospitalized with acute decompensated heart failure
Observation:
Background information
Vital sign at admission and at discharge
Laboratory test, echocardiography, medication including furosemide at admission and at discharge at admission and at discharge
Sarcopenia test (grip strength, short physical performance battery, appendicular skeletal muscle mass by bio impedance analysis)
Calf circumference
Tongue pressure
Biomarker (BDNF; brain-derived neurotrophic factor)
Primary outcome:
Composite endpoint including all-cause death and heart failure rehospitalization
Secondary outcome:
In-hospital death
All-cause death
Cardiac death
Heart failure rehospitalization
Management information
Registered date
| 2021 | Year | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051234
