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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020373
Receipt No. 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

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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
Email 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
Email kabu@jichi.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022408

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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