UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034697
Receipt number R000039530
Scientific Title Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.
Date of disclosure of the study information 2018/11/01
Last modified on 2020/05/19 05:20:13

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Basic information

Public title

Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.

Acronym

Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.

Scientific Title

Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.

Scientific Title:Acronym

Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.

Region

Japan


Condition

Condition

heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigated the relationship between 99mTc-MIBI and exercise capacity in patients with acute decompensated heart failure six months after a discharge and a discharge.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To investigated the relationship between 99mTc-MIBI and exercise capacity in patients with acute decompensated heart failure six months after a discharge and a discharge.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

99mTc-MIBI and exercise tolerance

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Improvement of acute signs and symptoms of heart failure.

Key exclusion criteria

Patient with severe aortic stenosis and mitral stenosis.
Patients under dialysis.
Patients with chronic lung disease.
Patients following stroke with neurological deficit.
Patients with severe liver cirrhosis and failure.
Patients with life-threatening malignancy.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Takao
Middle name
Last name Kato

Organization

Juntendo University School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

113-8431

Address

3-1-3 Hongo Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

tkatou@juntendo.ac.jp


Public contact

Name of contact person

1st name Takao
Middle name
Last name Kato

Organization

Juntendo University School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

113-8431

Address

3-1-3 Hongo Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

tkatou@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of Cardiovascular Medicine, Juntendo University School of Medicine

Address

3-1-3, Hongo, bunkyo-ku, Tokyo

Tel

0338133111

Email

tkatou@juntendo.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

2018 Year 11 Month 01 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 11 Month 01 Day

Date of IRB

2019 Year 02 Month 15 Day

Anticipated trial start date

2019 Year 02 Month 15 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 30 Day

Last modified on

2020 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039530


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name