UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007707
Receipt number R000009058
Scientific Title Effect of cardiac resynchronization therapy on coronary flow reserve, endotherial function, and cardiac autonomic function.
Date of disclosure of the study information 2012/04/10
Last modified on 2023/04/18 14:50:50

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Basic information

Public title

Effect of cardiac resynchronization therapy on coronary flow reserve, endotherial function, and cardiac autonomic function.

Acronym

Effect of cardiac resynchronization therapy on coronary flow reserve, endotherial function, and cardiac autonomic function.

Scientific Title

Effect of cardiac resynchronization therapy on coronary flow reserve, endotherial function, and cardiac autonomic function.

Scientific Title:Acronym

Effect of cardiac resynchronization therapy on coronary flow reserve, endotherial function, and cardiac autonomic function.

Region

Japan


Condition

Condition

heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Cardiac resynchronization therapy (CRT) is the established treatment for patients with chronic and severe heart failure. The aim of this study was to assess the effect of CRT on coronary flow reserve (CFR) determined non-invasively by transthoracic echocardiography (TTE), endotherial function, and cardiac autonomic function in patients with heart failure

Basic objectives2

Others

Basic objectives -Others

Prediction of response to CRT

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

coronary flow reserve (CFR), cardiac autonomic function, endotherial function

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with heart failure (NYHA III-IV, QRS >130 ms, left ventricular ejection fraction <0.35) who undergo CRT

Key exclusion criteria

patients with contraindication for ATP or phenylephrine

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Kunio
Middle name
Last name Yufu

Organization

Faculty of Medicine, Oita University

Division name

Department of Cardiology

Zip code

879-5593

Address

1-1 Idaigaoka, Hasama, Yufu, Oita, Japan

TEL

097-586-5797

Email

yufukuni@oita-u.ac.jp


Public contact

Name of contact person

1st name Kunio
Middle name
Last name Yufu

Organization

Faculty of Medicine, Oita University

Division name

Department of Cardiology

Zip code

879-5593

Address

1-1 Idaigaoka, Hasama, Yufu, Oita, Japan

TEL

097-586-5797

Homepage URL


Email

junkan@oita-u.ac.jp


Sponsor or person

Institute

Department of Cardiology, Faculty of Medicine, Oita University

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiology, Faculty of Medicine, Oita University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB, Faculty of Medicine, Oita University

Address

1-1 Idaigaoka, Hasama, Yufu, Oita, Japan

Tel

097-549-4411

Email

gcrcjimu@oita-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



Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 10 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

80

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

Completed

Date of protocol fixation

2012 Year 03 Month 21 Day

Date of IRB

2012 Year 03 Month 21 Day

Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We observe the effect of CRT on coronary flow reserve (CFR) determined non-invasively by transthoracic echocardiography (TTE), general endotherial function, and cardiac autonomic function in patients with heart failure.


Management information

Registered date

2012 Year 04 Month 09 Day

Last modified on

2023 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009058


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name