UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040648 |
|---|---|
| Receipt number | 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 | 2023/12/08 18:34:37 |
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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
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
takano.makoto@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna university
Institute
Department
Personal name
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
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
| 2023 | Year | 12 | Month | 01 | Day |
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
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042909
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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