UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042099 |
|---|---|
| Receipt number | R000048036 |
| Scientific Title | Observational Study of Prediction of Disease Progress in Patients with Idiopathic Cardiomyopathy |
| Date of disclosure of the study information | 2020/10/13 |
| Last modified on | 2020/10/13 00:12:52 |
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Basic information
Public title
Observational Study of Prediction of Disease Progress in Patients with Idiopathic Cardiomyopathy
Acronym
Observational Study of Prediction of Disease Progress in Patients with Idiopathic Cardiomyopathy
Scientific Title
Observational Study of Prediction of Disease Progress in Patients with Idiopathic Cardiomyopathy
Scientific Title:Acronym
Observational Study of Prediction of Disease Progress in Patients with Idiopathic Cardiomyopathy
Region
| Japan |
Condition
Condition
Idiopathic cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to establish methods for early diagnosis and prediction of prognosis, leading to effective treatment in patients with idiopathic cardiomyopathy.
Basic objectives2
Others
Basic objectives -Others
This study aims to establish models for predicting the progression of cardiac and organ dysfunction in patients with idiopathic cardiomyopathy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All cause death, hospitalization due to worsening heart failure, lethal arrhythmia, LVAD implantation, and heart transplantation.
Key secondary outcomes
Organ failure, cardiac biomarker, and left ventricular reverse remodeling.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are suspected to be an idiopathic cardiomyopathy by clinical history, physical findings, or examinations.
2) In addition, patients diagnosed with idiopathic cardiomyopathy between 2000 and 2017 are retrospectively included.
3) Written informed consent was obtained from all patients.
Key exclusion criteria
If no consent is obtained.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2147
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Okumura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2147
Homepage URL
takaoku@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Tel
052-744-2061
ethics@med.nagoya-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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Cohort study
Recruitment method: All patients who are visit our institution from June 2017 to March 2017 and who meet the inclusion criteria. Additionally, all patients who were diagnosed with idiopathic cardiomyopathy at our institution between 2000 and 2017.
Evaluation: We assess whether variables can predict prognosis, severity of heart failure, and multi-organ failure.
Management information
Registered date
| 2020 | Year | 10 | Month | 13 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048036
