UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017507
Receipt number R000020294
Scientific Title Study on the role of intramyocellular lipid (IMCL) in patients with heart failure (HF)
Date of disclosure of the study information 2015/05/11
Last modified on 2015/05/11 20:28:42

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Basic information

Public title

Study on the role of intramyocellular lipid (IMCL) in patients with heart failure (HF)

Acronym

HF and IMCL

Scientific Title

Study on the role of intramyocellular lipid (IMCL) in patients with heart failure (HF)

Scientific Title:Acronym

HF and IMCL

Region

Japan


Condition

Condition

Heart faiulre

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether IMCL is increased in patients with HF

Basic objectives2

Others

Basic objectives -Others

observational study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

IMCL

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

HF patients (NYHA I-III) with dilated cardiomyopathy (DCM) with left ventricular ejection fraction (LVEF) less than 40%

Key exclusion criteria

1) Patients who had the implanted mechanical devices
2) Patients wiht NYHA IV
3) Patients who could not perform exercise testing
4) Patients with diabetes mellitus (DM)

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Tsutsui

Organization

Hokkaido University School of Medicine

Division name

Cardiovascular Medicine

Zip code


Address

Kita-15, Nishi-7, Kita-ku, Sapporo

TEL

011-706-6973

Email

cvsecret@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shintaro Kinugawa

Organization

Hokkaido University School of Medicine

Division name

Cardiovascular Medicine

Zip code


Address

Kita-15, Nishi-7, Kita-ku, Sapporo

TEL

011-706-6973

Homepage URL


Email

tuckahoe@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University School of Medicine, Cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Science, and Culture

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 05 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Peak oxygen uptake (VO2) and anaerobic threshold were significantly lower in HF compared to control. Maximal phosphocreatine loss assessed by 31P-magnetic resonance spectroscopy (MRS) during unilateral plantar flexion exercise was significantly greater in DCM. IMCL content assessed by 1H-MRS was significantly increased in DCM. There was a significant correlation among peak VO2, maximal phosphocreatine loss, and skeletal muscle IMCL content.

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

2007 Year 06 Month 14 Day

Date of IRB


Anticipated trial start date

2007 Year 09 Month 18 Day

Last follow-up date

2009 Year 10 Month 15 Day

Date of closure to data entry

2009 Year 11 Month 15 Day

Date trial data considered complete

2010 Year 03 Month 30 Day

Date analysis concluded

2011 Year 06 Month 01 Day


Other

Other related information

Energy metabolism in the skeletal muscle and IMCL were measured by using MR spectroscopy, and the association among them was investigated.


Management information

Registered date

2015 Year 05 Month 11 Day

Last modified on

2015 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020294


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name