UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051033 |
|---|---|
| Receipt number | R000058185 |
| Scientific Title | A multicenter prospective observational study on the prognosis of patients with acute heart failure who performed underwent cardiac rehabilitation |
| Date of disclosure of the study information | 2023/05/11 |
| Last modified on | 2023/05/10 22:58:11 |
* 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
A multicenter prospective observational study on the prognosis of patients with acute heart failure who performed underwent cardiac rehabilitation
Acronym
IYO-AHF study
Scientific Title
A multicenter prospective observational study on the prognosis of patients with acute heart failure who performed underwent cardiac rehabilitation
Scientific Title:Acronym
IYO-AHF study
Region
| Japan |
Condition
Condition
Acute heart failure/Acute decompensated heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prognosis of patients with acute/decompensated heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endpoint of all-cause mortality and all-cause hospitalization 1 year after discharge
Key secondary outcomes
All-cause mortality and all-cause hospitalization rates
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years-old
Walkable before hospitalization
No life crisis due to terminal disease (cancer etc.)
Not scheduled for valve replacement, coronary artery bypass surgery, or other surgery after discharge, except for PCI
Only the first admission during the study period will be enrolled
Key exclusion criteria
Within 1 year of prognosis (due to terminal disease)
Physical assessment contraindicated (eg, 6MWT contraindicated due to hemodynamic instability)
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Nakaya |
Organization
Uwajima City Hospital
Division name
Department of Rehabilitation
Zip code
798-8510
Address
1-1 Goten-machi, Uwajima city, Ehime
TEL
0895-25-1111
y.nakaya.pt@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Nakaya |
Organization
Uwajima City Hospital
Division name
Department of Rehabilitation
Zip code
798-8510
Address
1-1 Goten-machi, Uwajima city, Ehime
TEL
0895-25-1111
Homepage URL
y.nakaya.pt@gmail.com
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yawatahama City General Hospital
Matsuyama Shimin Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Uwajima City Hospital
Address
1-1 Goten-machi, Uwajima city, Ehime
Tel
0895-25-1111
y.nakaya.pt@gmail.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
| 2023 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2023 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058185
