UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041278
Receipt number R000047144
Scientific Title Prognostic value of baroreflex sensitivity in patients with atrial and ventricular arrhythmia.
Date of disclosure of the study information 2020/08/02
Last modified on 2024/01/04 12:47:57

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Prognostic value of baroreflex sensitivity in patients with atrial and ventricular arrhythmia.

Acronym

Association of BRS with Arrhythmia.

Scientific Title

Prognostic value of baroreflex sensitivity in patients with atrial and ventricular arrhythmia.

Scientific Title:Acronym

Association of BRS with Arrhythmia.

Region

Japan


Condition

Condition

Atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the prognostic value of baroreflex sensitivity in patients with atrial fibrillation.

Basic objectives2

Others

Basic objectives -Others

To investigate the prognostic value of baroreflex sensitivity in patients with atrial fibrillation.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Recurrence of atrial fibrillation, Hospitalization due to heart failure, Stroke, Cardiovasculat death

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who are going to undergo catheter ablation for atrial fibrillation.

Key exclusion criteria

uncontrollable heart failure
uncontrollable hypertension
severe dysfunction of liver and kidney, cerebrovascular disease
Allergy to phenylephrine

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Naohiko
Middle name
Last name Takahashi

Organization

Oita University

Division name

Faculty of Medicine

Zip code

879-5593

Address

1-1 idaigaoka Hasama-machi, Yufu, Oita

TEL

0975866166

Email

takanao@oita-u.ac.jp


Public contact

Name of contact person

1st name Miho
Middle name
Last name Miyoshi

Organization

Oita University

Division name

Faculty of Medicine

Zip code

879-5593

Address

1-1 idaigaoka Hasama-machi, Yufu, Oita

TEL

0975866166

Homepage URL


Email

h-miho@oita-u.ac.jp


Sponsor or person

Institute

Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiology and Clinical Examination, 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

Faculty of Medicine, Oita University

Address

1-1 idaigaoka Hasama-machi, Yufu, Oita

Tel

0975866166

Email

hkondo@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

2020 Year 08 Month 02 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

Completed

Date of protocol fixation

2018 Year 04 Month 01 Day

Date of IRB

2018 Year 04 Month 01 Day

Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry

2023 Year 12 Month 31 Day

Date trial data considered complete

2024 Year 06 Month 30 Day

Date analysis concluded

2024 Year 06 Month 30 Day


Other

Other related information

Nothing to report


Management information

Registered date

2020 Year 08 Month 02 Day

Last modified on

2024 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047144


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name