UMIN-CTR Clinical Trial

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
Last 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
Email	koichi-nakao@saiseikaikumamoto.jp

Public contact
1st 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
Email	tatsunori.murata@crecon.jp

Sponsor
Institute	Saiseikai Kumamoto Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039020