UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010119
Receipt number R000011849
Scientific Title Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients
Date of disclosure of the study information 2013/03/01
Last modified on 2013/02/25 22:02:39

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Basic information

Public title

Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients

Acronym

Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients

Scientific Title

Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients

Scientific Title:Acronym

Inhibitory effect of cardiac resynchronization therapy on sympathetic nerve activity in chronic heart failure patients

Region

Japan


Condition

Condition

Chronic heart failure

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess changes in cardiac adrenergic activity with cardiac resynchronization therapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Effect of cardiac resynchronization therapy on muscle sympathetic nerve activity, 24 and 48 week after implantation.

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 weeks-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Twenty consecutive patients with advanced heart failure who meet clinical criteria for a CRT implantation ( LVEF<35%, NYHA function class 3 or 4, QRS durationz>120ms and optimal medical therapy).

Key exclusion criteria

Patints with recent myocardial infarction, cardiac surgery(<3 months), unstable medical conition, and chronic atrial fibrillation are excluded.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuichi Kaneko

Organization

Internal Medicine, Kanazawa University Hospital

Division name

Disease Control and Homeostasis

Zip code


Address

13-1, Takara-machi, Kanazawa, Ishikawa, Japan

TEL

076-265-2000

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Internal Medicine, Kanazawa University Hospital

Division name

Disease Control and Homeostasis

Zip code


Address

13-1, Takara-machi, Kanazawa, Ishikawa, Japan

TEL

076-265-2000

Homepage URL


Email



Sponsor or person

Institute

Internal Medicine, Kanazawa University Hospital Disease Control and Homeostasis

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

Kanazawa medical center

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

金沢大学附属病院(石川県)、金沢医療センター(石川県)


Other administrative information

Date of disclosure of the study information

2013 Year 03 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

Preinitiation

Date of protocol fixation

2013 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective study


Management information

Registered date

2013 Year 02 Month 25 Day

Last modified on

2013 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011849


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name