UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030753 |
|---|---|
| Receipt number | 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 | 2023/11/12 04:39:09 |
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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 | Takahiko |
| Middle name | |
| Last name | Kinjo |
Organization
Hirosaki university hospital
Division name
Department of Cardiology and Nephrology
Zip code
0368356
Address
Zaifu-cho 5 Hirosaki 036-8562 JAPAN
TEL
0172-39-5375
kinjo@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Iwaya |
| Middle name | |
| Last name | Tomomi |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Advance Management of Cardiac Arrhythmias
Zip code
0368356
Address
Zaifu-cho 5 Hirosaki 036-8562 JAPAN
TEL
0172-39-5144
Homepage URL
iwaya0713@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki university hospital
Institute
Department
Personal name
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
Hirosaki university hospital IRB
Address
zaifu-cho 5
Tel
0172-33-511
kinjo1984@gmail.com
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
https://onlinelibrary.wiley.com/doi/10.1002/joa3.12934
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/joa3.12934
Number of participants that the trial has enrolled
21
Results
Six patients showed fused atrial activation. Post-landiolol administration, the effective refractory period in AP stayed unchanged, while that of the AV node was prolonged. Wenckebach pacing rate via retrograde AV node decreased with landiolol, reducing the minimum ventricular pacing rate for atrial activation dissociation.
Results date posted
| 2023 | Year | 11 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled 149 patients with PSVT during the study period. Of these, 123 were excluded from this study because 114 patients were diagnosed with atrioventricular nodal reentrant tachycardia, seven with atrial tachycardia, and two with decremental bypass tract. Twenty-six patients were diagnosed with orthodromic AV reciprocating tachycardia (ORT) using a retrograde accessory pathway. Of them, three patients with intermittent preexcitation syndrome and two patients with multiple accessory pathways were excluded.
Participant flow
We enrolled 149 patients with PSVT during the study period. Of these, 123 were excluded from this study because 114 patients were diagnosed with atrioventricular nodal reentrant tachycardia, seven with atrial tachycardia, and two with decremental bypass tract. Twenty-six patients were diagnosed with orthodromic AV reciprocating tachycardia (ORT) using a retrograde accessory pathway. Of them, three patients with intermittent preexcitation syndrome and two patients with multiple accessory pathways were excluded.
Adverse events
No adverse events, including landiolol-related adverse events, were observed.
Outcome measures
The minimal ventricular pacing rate dissociating a fusion of atrial activation was high at baseline; however, landiolol decreased the minimum ventricular pacing rate. Before and after landiolol administration, the ERP and conduction time of AP were unchanged. The conduction time via AP was unchanged, although the pacing rate increased before and after landiolol administration. The ERP of the AV node was prolonged after landiolol administration. The conduction time of the AV node was prolonged but insignificant after landiolol administration. The Wenckebach pacing rate of retrograde AV node conduction decreased after landiolol administration. All the patients underwent radiofrequency catheter ablation during RV pacing under continuous intravenous infusion of landiolol. The current was initiated at 20W and increased to 30W. Acute success was achieved in all the patients. No adverse events, including landiolol-related adverse events, were observed. During the mean follow-up period of 51 weeks, no patient experienced tachycardia recurrence.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035120
