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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024140
Receipt No. R000027796
Scientific Title effect of change in heart rate on valvular disease and ventricular function
Date of disclosure of the study information 2016/11/01
Last modified on 2016/09/23

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Basic information
Public title effect of change in heart rate on valvular disease and ventricular function
Acronym effect of change in heart rate on valvular disease and ventricular function
Scientific Title effect of change in heart rate on valvular disease and ventricular function
Scientific Title:Acronym effect of change in heart rate on valvular disease and ventricular function
Region
Japan

Condition
Condition valvuler disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to study the effect of change in heart rate on valvuler heart disease and ventricular function.
Basic objectives2 Others
Basic objectives -Others to assess the optimum heart rate of valvular disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes severity of valvular disease
ventricular function
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We change heart rate of pacemaker every 10 bpm from 50 to 100bpm. We examine a transthoracic echocardiography to assess the effect of change in heart rate on severity of valvular disease and ventricular function. We return heart rate to standard setting after testing
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
90 years-old >
Gender Male and Female
Key inclusion criteria patients with terminal pacemaker whose maker is St.Jude Medical or Medtronic
Key exclusion criteria acute coronary syndrome
severe aortic valve disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Masuyama
Organization Hyogo college of Medicine
Division name Cardiovascular Division, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya 663-8501, Japan
TEL 0798-45-6553
Email masuyama@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miho Fukui
Organization Hyogo college of Medicine
Division name Cardiovascular Division, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya 663-8501, Japan
TEL 0798-45-6553
Homepage URL
Email m-fukui@hyo-med.ac.jp

Sponsor
Institute Hyogo college of Medicine
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
2016 Year 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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
2016 Year 09 Month 23 Day
Last modified on
2016 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027796

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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