UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024140 |
|---|---|
| Receipt number | 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 16:42:18 |
* 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
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
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
m-fukui@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of Medicine
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027796
