UMIN-CTR Clinical Trial

Basic information
Public title	The Actual Situation and Prognosis Outcomes of Underutilization of CRT treatment in Heart Failure patients with Reduced Ejection Fraction
Acronym	The Actual Situation and Prognosis Outcomes of Underutilization of CRT treatment in Heart Failure patients with Reduced Ejection Fraction
Scientific Title	The Actual Situation and Prognosis Outcomes of Underutilization of CRT treatment in Heart Failure patients with Reduced Ejection Fraction
Scientific Title:Acronym	The Actual Situation and Prognosis Outcomes of Underutilization of CRT treatment in Heart Failure patients with Reduced Ejection Fraction
Region	Japan

Condition
Condition	Heart Failure patients with Reduced Ejection Fraction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we consider CRT (ventricular resynchronization therapy) treatment as one of the standard treatments for heart failure treatment, and target heart failure patients with reduced ejection fraction. CRT treatment should be treated as a heart failure treatment, and a retrospective study on clinical outcome of such a patient should be performed.
Basic objectives2	Others
Basic objectives -Others	we confirm the rate of intraventricular conduction disorder in HFrEF patients with NYHA grade 2 or higher, and clarify the patients who should be treated with CRT as a treatment for heart failure.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CRT treatment should identify patients who should be treated as heart failure, and clinical outcomes regarding the clinical course of such patients (all mortality: cardiogenic, non-cardiogenic, heart failure hospitalization events ), this is retrospective study.
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	18 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with heart failure who have left ventricular ejection fraction less than 50% and chronic heart failure with contraction failure more than NYHA 2.
Key exclusion criteria	Patients who treated CRT treatment.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Takano
Organization	St. Marianna University Yokohama City Seibu Hospital
Division name	Division of Cardiology
Zip code	241-0811
Address	1197-1 Yasashi-cyou, Asahi-Ku, Yokohama City, Kanagawa
TEL	045-366-1111
Email	takano.makoto@marianna-u.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Takano
Organization	St. Marianna University Yokohama City Seibu Hospital
Division name	Division of Cardiology
Zip code	241-0811
Address	1197-1 Yasashi-cyou, Asahi-Ku, Yokohama City, Kanagawa
TEL	045-366-1111
Homepage URL
Email	takano.makoto@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University Yokohama City Seibu Hospital
Institute
Department

Funding Source
Organization	Medtronic Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Marianna University Yokohama City Seibu Hospital
Address	1197-1 Yasashi-cyou, Asahi-Ku, Yokohama City, Kanagawa
Tel	045-366-1111
Email	takano.makoto@marianna-u.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 07 Month 27 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	2020 Year 07 Month 22 Day
Date of IRB	2020 Year 07 Month 13 Day
Anticipated trial start date	2020 Year 07 Month 22 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 04 Month 01 Day

Other
Other related information	Retrospective observational study.

Management information
Registered date	2020 Year 07 Month 27 Day
Last modified on	2021 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047066