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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028167
Receipt No. R000032245
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-Implanted Patients
Date of disclosure of the study information 2017/07/11
Last modified on 2017/07/10

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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-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-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-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-Implanted Patients
Region
Japan

Condition
Condition ventricular tachycardia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clear the hemodynamic response during ventricular rapid pacing and determine the factors that affect the blood pressure during VT in HF patients.
Basic objectives2 Others
Basic objectives -Others risk stratification
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between the cycle length of ventricular pacing and hemodynamics during ventricular tachycardia
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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 ventricular pacing
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
19 years-old <=
Age-upper limit
88 years-old >=
Gender Male and Female
Key inclusion criteria The patients who underwent RFCA for paroxysmal/persistent atrial fibrillation and paroxysmal supraventricular tachycardia , premature ventricular contraction and idiopathic ventricular tachycardia or electrophysiologic study.
Key exclusion criteria The patients with coronary artery disease, aortic valve disease and cardiovascular events within three months.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuki Noda
Organization Iwate Prefectural Central Hospital
Division name Department of Cardiology
Zip code
Address Ueda 1-4-1, Morioka city, Iwate prefecture, Japan
TEL 81-19-653-1151
Email a0mb1069-thk@umin.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Noda
Organization Iwate Prefectural Central Hospital
Division name Department of Cardiology
Zip code
Address Ueda 1-4-1, Morioka city, Iwate prefecture, Japan
TEL 81-19-653-1151
Homepage URL
Email a0mb1069-thk@umin.jp

Sponsor
Institute Department of Cardiology, Iwate Prefectural Central Hospital
Institute
Department

Funding Source
Organization none
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
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 07 Month 11 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
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 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

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2017 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032245

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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