UMIN-CTR Clinical Trial

Basic information
Public title	The retrospective exploration for the new type of medicines for congestive heart failure
Acronym	The retrospective exploration for the new type of medicines for congestive heart failure
Scientific Title	The retrospective exploration for the new type of medicines for congestive heart failure
Scientific Title:Acronym	The retrospective exploration for the new type of medicines for congestive heart failure
Region	Japan

Condition
Condition	congestive heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To observe the patients who are treated by the new medicines for congestive heart failure examined by echocardiography and many other modalities
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The echocardiographic indices
Key secondary outcomes

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1. The patients who are treated with Ivabrazin, Dapagliflozin, Sacubitril valsartan sodium hydrate 2. The patients with examination with blood test and echocardiography
Key exclusion criteria	Discontinuation
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Noriaki Middle name Last name Iwahashi
Organization	Yokohama City University Medical center
Division name	Division of Cardiology
Zip code	232-0024
Address	4-57 Urafune-cho Yokohama
TEL	045-261-5656
Email	niwahash@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Noriaki Middle name Last name Iwahashi
Organization	Yokohama City University Medical Center
Division name	Division of Cardiology
Zip code	232-0024
Address	4-57 Urafune-cho Minami-ku Yokohama
TEL	045-261-5656
Homepage URL
Email	niwahash@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	Yokohama City University Medical Center
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	YCU novel and clinical trail center
Address	3-9 Fukura Kanazawa-ku Yokohama
Tel	0457872800
Email	nextjim1@yokohama-cu.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	2020 Year 12 Month 31 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	2020 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date	2020 Year 12 Month 31 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective

Management information
Registered date	2020 Year 12 Month 08 Day
Last modified on	2020 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048723