UMIN-CTR Clinical Trial

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
Email	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
Email	takaoku@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048036