UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041212 |
|---|---|
| Receipt number | R000047066 |
| Scientific Title | The Actual Situation and Prognosis Outcomes of Underutilization of CRT treatment in Heart Failure patients with Reduced Ejection Fraction |
| Date of disclosure of the study information | 2020/07/27 |
| Last modified on | 2021/10/14 10:01:43 |
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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
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
takano.makoto@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University Yokohama City Seibu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047066
| 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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