UMIN-CTR Clinical Trial

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	2020 Year 05 Month 21 Day
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	Approved by Ethics Review Committee

Management information
Registered date	2020 Year 03 Month 12 Day
Last modified on	2020 Year 09 Month 13 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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