UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028879
Receipt number R000033052
Scientific Title Factors Affecting the Hemodynamic Instability during Ventricular Rapid Pacing: Differential Predictors in Patients with Heart Failure with Preserved Ejection Fraction and Cardiac Resynchronized Therapy Device Implanted Patients
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/29 14:27:39

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Basic information

Public title

Factors Affecting the Hemodynamic Instability during Ventricular Rapid Pacing: Differential Predictors in Patients with Heart Failure with Preserved Ejection Fraction and Cardiac Resynchronized Therapy Device Implanted Patients

Acronym

Factors Affecting the Hemodynamic Instability during Ventricular Rapid Pacing: Differential Predictors in Patients with Heart Failure with Preserved Ejection Fraction and Cardiac Resynchronized Therapy Device Implanted Patients

Scientific Title

Factors Affecting the Hemodynamic Instability during Ventricular Rapid Pacing: Differential Predictors in Patients with Heart Failure with Preserved Ejection Fraction and Cardiac Resynchronized Therapy Device Implanted Patients

Scientific Title:Acronym

Factors Affecting the Hemodynamic Instability during Ventricular Rapid Pacing: Differential Predictors in Patients with Heart Failure with Preserved Ejection Fraction and Cardiac Resynchronized Therapy Device Implanted Patients

Region

Japan


Condition

Condition

ventricular tachycardia

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the hemodynamic response during rapid ventricular pacing and identify factors that affect blood pressure during VT.

Basic objectives2

Others

Basic objectives -Others

To clear the hemodynamic stability during ventricular tachycardia

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

hemodynamic changes during rapid ventricular pacing and clinical VT

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Catheter study

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

18 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with ventricular tachycardia

Key exclusion criteria

patients with acute heart failure within 3 months and/or coronary artery disease

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuki Noda

Organization

Iwate Prefectural Central Hospital, Morioka, Iwate, Japan

Division name

Department of Cardiology

Zip code


Address

1-4-1 Ueda, Morioka city, Iwate prefecture, Japan

TEL

+81-019-653-1151

Email

a0mb1069-thk@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuki Noda

Organization

Iwate Prefectural Central Hospital, Morioka, Iwate, Japan

Division name

Department of Cardiology

Zip code


Address

1-4-1 Ueda, Morioka city, Iwate prefecture, Japan

TEL

+81-019-653-1151

Homepage URL


Email

a0mb1069-thk@umin.ac.jp


Sponsor or person

Institute

Iwate Prefectural Central Hospital, Morioka, Iwate, Japan

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


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

2017 Year 09 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

2017 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 09 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



Management information

Registered date

2017 Year 08 Month 29 Day

Last modified on

2017 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033052


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name