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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030753
Receipt No. R000035120
Scientific Title A study on efficacy of autonomic nerve regulating agents on manifestation of accessory pathway in paroxysmal supraventricular tachycardia patients
Date of disclosure of the study information 2018/01/11
Last modified on 2018/07/12

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Basic information
Public title A study on efficacy of autonomic nerve regulating agents on manifestation of accessory pathway in paroxysmal supraventricular tachycardia patients
Acronym Importance of autonomic nerve regulating agents in paroxysmal supraventricular tachycardia patients
Scientific Title A study on efficacy of autonomic nerve regulating agents on manifestation of accessory pathway in paroxysmal supraventricular tachycardia patients
Scientific Title:Acronym Importance of autonomic nerve regulating agents in paroxysmal supraventricular tachycardia patients
Region
Japan

Condition
Condition Paroxysmal supraventricular tachycardia (PSVT)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was 1) to investigate whether landiolol affect the ERP or conduction times of AP and AVN, and 2) to investigate the efficacy and safety of landiolol in catheter ablation of AP.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effective refractory period of and conduction time of accessory pathway.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Landiolol
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
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria A) Patients who satisfy paroxysmal supraventricular tachycardia ablation adaptation criteria in Japan.
B) Patients who have accessory pathway.
C) After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding.
Key exclusion criteria A) Patients who have allergy for landiolol.
B) Patients who have contraindications for beta blocker (uncontrolled bronchial asthma, shock, coronary spastic angina, peripheral artery disease).
C) Patients with heart rate of 40 times/min or less
D) Patients with low left ventricular function (left ventricular ejection fraction: 25% or less).
E) Patients who are not willing to participate in the study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiko Kinjo
Organization Hirosaki university hospital
Division name Advance emergency and critical care center
Zip code
Address Zaifu-cho 5 Hirosaki 036-8562 JAPAN
TEL 0172-39-5375
Email kinjo@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Iwaya
Organization Hirosaki University Graduate School of Medicine
Division name Department of Advance Management of Cardiac Arrhythmias
Zip code
Address Zaifu-cho 5 Hirosaki 036-8562 JAPAN
TEL 0172-39-5144
Homepage URL
Email iwaya0713@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki university hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Aomori prefectural central hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 弘前大学医学部附属病院(青森県)、青森県立中央病院(青森県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 11 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 15 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
2018 Year 01 Month 10 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035120

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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