UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020373 |
|---|---|
| Receipt number | R000022408 |
| Scientific Title | Nighttime heart rate changes after pacemaker implantation and the change of autonomic nervous activity, blood pressure circadian variation and marker of heart failure in patients with sick sinus syndrome |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2019/03/20 17:46:53 |
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Basic information
Public title
Nighttime heart rate changes after pacemaker implantation and the change of autonomic nervous activity, blood pressure circadian variation and marker of heart failure in patients with sick sinus syndrome
Acronym
Study of pacemaker settings, heart rate and circadian blood pressure change
Scientific Title
Nighttime heart rate changes after pacemaker implantation and the change of autonomic nervous activity, blood pressure circadian variation and marker of heart failure in patients with sick sinus syndrome
Scientific Title:Acronym
Study of pacemaker settings, heart rate and circadian blood pressure change
Region
| Japan |
Condition
Condition
Sick sinus syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate nighttime heart rate changes after pacemaker implantation and the change of autonomic nervous activity, blood pressure circadian variation and marker of heart failure in patients with sick sinus syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of NT-ProBNP, changes in blood catecholamine concentration at 6 and 12 months after the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A:
[0 to 6 months]
Lower rate limits of 60 beats per minute in daytime, 50 beats per minute in nighttime.
[6 to 12 months]
Lower rate limits of 60 beats per minute in daytime and nighttime.
Interventions/Control_2
Group B:
[0 to 6 months]
Lower rate limits of 60 beats per minute in daytime and nighttime.
[6 to 12 months]
Lower rate limits of 60 beats per minute in daytime, 50 beats per minute in nighttime.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are implanted DDD pace maker for their symptomatic sick sinus syndrome.
(2) NTProBNP >=55.
(3) Male or female, age 20 to 84 years.
(4) Patients with written informed consent.
Key exclusion criteria
(1)Less than 1 month since onset of myocardial infarction, unstable angina or peripheral artery disease.
(2) Patients with systemic embolism, or less than 3 month since onset of stroke.
(3) Patients with malignant tumor (no improvement in symptoms).
(4) Life expectancy of less than one year due to other pre-existing diseases.
(4) Patients judged as unsuitable for the study by study investigators.
Target sample size
67
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan
TEL
0285-58-7344
kkario@jichii.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kabutoya |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan
TEL
0285-58-7344
Homepage URL
kabu@jichi.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken 329-0498, Japan
Tel
0285-58-8933
rinri@jichi.ac.jp
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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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
10
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
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022408
