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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040648
Receipt No. R000042909
Scientific Title Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients
Date of disclosure of the study information 2020/06/05
Last modified on 2020/06/04

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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
2021 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
2020 Year 06 Month 04 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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