UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034228 |
|---|---|
| Receipt number | R000039020 |
| Scientific Title | Effects of pimobendan on prolonging time to rehospitalization or frequency of readmission in patients with heart failure.-a retrospective cohort study using medical administrative database-(PREFER study) |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2019/03/27 17:41:38 |
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Basic information
Public title
Effects of pimobendan on prolonging time to rehospitalization or frequency of readmission in patients with heart failure.-a retrospective cohort study using medical administrative database-(PREFER study)
Acronym
Effects of pimobendan on prolonging time to rehospitalization or frequency of readmission in patients with heart failure.-a retrospective cohort study using medical administrative database-(PREFER study)
Scientific Title
Effects of pimobendan on prolonging time to rehospitalization or frequency of readmission in patients with heart failure.-a retrospective cohort study using medical administrative database-(PREFER study)
Scientific Title:Acronym
Effects of pimobendan on prolonging time to rehospitalization or frequency of readmission in patients with heart failure.-a retrospective cohort study using medical administrative database-(PREFER study)
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study exploratory the influence of pimobendan prescription on prolonging time to rehospitalization and/or incident of readmission for heart failure patient utilizing medical administrative database.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The time to rehospitalization and/or the incident of readmission in heart failure patient.
Key secondary outcomes
Number of re-hospitalization due to heart failure
Total number of hospitalizations
Frequency of specific adverse event for cardiotonic drugs
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 who have more than 2 records of hospitalization between the study target period from January 2010 to February 2018.
2. Patients who have more than 2 records of hospitalization under disease name of heart failure (ICD10 code:I11.0,I50) which is considered as a reason behind hospitalization.
3. Patients who have more than 2 records of outpatient visit after the start of the follow-up period.
4. Patient who are older than 20 years at the start of the follow-up period.
Key exclusion criteria
1.Patients whom had discharge JCS score was more than 1 at the hospitalization at the start of follow-up period.
2.Patients whom had discharge ADL score was less than 12 at the hospitalization at the start of follow-up period.
3.Patients who received pimobendan short term prescription.
4.Patients who have prescribed Vesnarinone,Denopamine,Docarpamine,during the follow-up period.
5.Patients who are prescribed inotropic injections(Dopamine hydrochloride,Dobutamine hydrochloride,PDE3inhibitors or Colforsin daropate hydrochloride) at the outpatient visits during the follow-up period.
6.Patients who had the following records within 90 days prior to the start of the follow-up period:
-Cardiac surgery(CABG,Valvuloplasty,Valve replacement surgery,etc.)(category code; K522,K554,K555,K5763,K5792,Including combined operation cases.)
-TAVI(category code;K555-02)
-Cardiac resynchronization therapy(CRT)(category code;K598,K598-02,K599-03,K599-04)
-PCI(category code;K546,K547,K548,K549,K550)
7.Patient who have the following diagnosis or procedures within the study target period:Malignant tumor(ICD10;C00-C97)
-Heart transplantation(category code;K605-02)
-Left Ventricular Assist Device(LVAD)(category code;C116,K603,K6042,K604-02)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Nakao |
| Middle name | |
| Last name | Koichi |
Organization
Saiseikai Kumamoto Hospital
Division name
Cardiology
Zip code
861-4193
Address
5-3-1 Chikami,Minami-ku,Kumamoto-city, Japan
TEL
096-351-8000
koichi-nakao@saiseikaikumamoto.jp
Public contact
Name of contact person
| 1st name | Murata |
| Middle name | |
| Last name | Tatsunori |
Organization
Crecon Medical Assessment Inc.
Division name
NA
Zip code
150-0002
Address
Nagai Memorial Bldg. 12-5,Shibuya 2-chome,Shibuya-ku,Tokyo Japan
TEL
03-3407-4491
Homepage URL
tatsunori.murata@crecon.jp
Sponsor or person
Institute
Saiseikai Kumamoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Toa Eiyo Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Kumamoto Hospital Ethics Committee
Address
5-3-1 Chikami,Minami-ku,Kumamoto-city, 861-4193,Japan
Tel
096-351-8513
naoko-takahashi@saiseikaikumamoto.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
| 2018 | Year | 10 | 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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 02 | Month | 22 | Day |
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2018 | Year | 09 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039020
| Research Plan | |
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| Registered date | File name |
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