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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028879
Receipt No. 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

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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
Institute Iwate Prefectural Central Hospital, Morioka, Iwate, Japan
Institute
Department

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
URL(English) https://upload.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


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