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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048036


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name