UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients
Acronym	Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients
Scientific Title	Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients
Scientific Title:Acronym	Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients
Region	Japan

Condition
Condition	Heart Failure Patients
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study considers CRT treatment as one of the standard treatments for heart failure treatment, and what standard heart failure treatments are available for heart failure patients with systolic dysfunction, including those in NYHA second-degree outpatient visits. The purpose of this study was to create a flow sheet and screen for whether or not heart failure patients with symptoms of NYHA of 2 degrees or more can confirm the rate of intraventricular conduction disorder and CRT treatment can be used as a standardized heart failure treatment .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	We consider CRT treatment as one of the treatments that should be established as a standard treatment for heart failure treatment, and what kind of standard heart failure treatment is given to patients with heart failure who have systolic dysfunction before CRT treatment.
Key secondary outcomes	We check the rate at which heart failure patients with systolic failure have intraventricular conduction disturbances, we use a flow sheet to screen whether CRT treatment can be used as a standardized heart failure treatment.

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The subjects are those who have undergone CRT and those who are considering CRT treatment.
Key exclusion criteria	None.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Takano
Organization	St. Marianna university
Division name	Division of Cardiology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-Ku, Kawasaki city, Kanagawa
TEL	044-977-8111
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
Division name	Division of Cardiology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-Ku, Kawasaki city, Kanagawa
TEL	044-977-8111
Homepage URL
Email	takano.makoto@marianna-u.ac.jp

Sponsor
Institute	St. Marianna university
Institute
Department

Funding Source
Organization	Medtronic
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
Address	2-16-1, Sugao, Miyamae-Ku, Kawasaki city, Kanagawa
Tel	044-977-8111
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 06 Month 05 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	Enrolling by invitation
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2019 Year 02 Month 26 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

In this study, we consider ventricular resynchronization therapy (CRT therapy) as one of the treatments that should be established as the standard treatment for heart failure treatment, and how to treat heart failure patients with systolic insufficiency, including patients undergoing NYHA 2 outpatient visit. Standard heart failure treatment is performed, and heart failure patients with NYHA2 or higher confirm the rate of intraventricular conduction disorder and prepare a flow sheet to screen whether CRT treatment can be used as a standardized heart failure treatment and screening.

Management information
Registered date	2020 Year 06 Month 04 Day
Last modified on	2021 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042909

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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