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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039790
Receipt No. R000045016
Scientific Title Impact of left ventricular stiffness by diastolic wall strain on atrial high rate episodes after pacemaker implantation
Date of disclosure of the study information 2020/05/12
Last modified on 2020/03/12

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Basic information
Public title Impact of left ventricular stiffness by diastolic wall strain on atrial high rate episodes after pacemaker implantation
Acronym LEADER study
Scientific Title Impact of left ventricular stiffness by diastolic wall strain on atrial high rate episodes after pacemaker implantation
Scientific Title:Acronym LEADER study
Region
Japan

Condition
Condition Patients scheduled for pacemaker implantation without a history of atrial fibrillation
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidating predictors of patients with asymptomatic atrial fibrillation and initial atrial fibrillation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes One year atrial tachycardia episode after pacemaker implantation
Key secondary outcomes (Before implanting a pacemaker)
Clinical data: age, gender, medical history, arrhythmia type, comorbid heart disease, past history, medications, height, weight, NYHA classification,
Blood sampling: Cre, Hb, UA, BNP, proBNP, Troponin-T
ECG: heart rate, QRS wave form, presence or absence of leg block,
Trans thoracic echocardiography:
Left atrial diameter, left atrial volume, left ventricular wall thickness, LV mass index, left ventricular end diastolic diameter, left ventricular systolic diameter, left ventricular ejection fraction, E wave, deceleration time, E / e` ratio, diastolic wall strain
(Pacemaker implantation technique)
Pacemaker type, setting, lead position (right atrial appendage, right ventricular apex, other)
(After pacemaker implantation)
Atrial hypertachycardia episode (atrial rate of 180 / min or more lasting for 6 minutes or more) at 1 month, 3 months, and 6 months after pacemaker visit.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients scheduled for pacemaker implantation without a history of atrial fibrillation
Key exclusion criteria Excludes patients with organic heart disease (cardiomyopathy, history of myocardial infarction, severe valvular disease), cardiac surgery, hemodialysis, and pacing-dependent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takanao
Middle name
Last name Mine
Organization Hyogo College of Medicine
Division name Department of Cardiovascular and Renal Medicine
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya, Japan
TEL 81-798-45-6553
Email mine@hyo-med.ac.jp

Public contact
Name of contact person
1st name Takanao
Middle name
Last name Mine
Organization Hyogo College of Medicine
Division name Department of Cardiovascular and Renal Medicine
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya, Japan
TEL 81-798-45-6553
Homepage URL
Email mine@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization no data
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kobe Ekisaikai Hosptal
Kawasaki Hospital
Meiwa Hospital
Hoshigaola Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Review Board of Hyogo College of Medicine
Address 1-1 Mukogawa-cho, Nishinomiya, Japan
Tel 0798-45-6066
Email rinri@hyo-med.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 兵庫医科大学病院(兵庫県)、神戸掖済会病院(兵庫県)、川崎病院(兵庫県)、明和病院(兵庫県)、JCHO 星ヶ丘医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 12 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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Under review by Ethics Review Committee

Management information
Registered date
2020 Year 03 Month 12 Day
Last modified on
2020 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045016

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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