UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036703 |
|---|---|
| Receipt number | R000041820 |
| Scientific Title | Bisoprolol Transdermal Patch for Perioperative Care of Non-cardiac Surgery in Patients with Hypertrophic Obstructive Cardiomyopathy |
| Date of disclosure of the study information | 2019/05/10 |
| Last modified on | 2019/05/10 11:35:30 |
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Basic information
Public title
Bisoprolol Transdermal Patch for Perioperative Care of Non-cardiac Surgery in Patients with Hypertrophic Obstructive Cardiomyopathy
Acronym
Bisoprolol Transdermal Patch for HOCM
Scientific Title
Bisoprolol Transdermal Patch for Perioperative Care of Non-cardiac Surgery in Patients with Hypertrophic Obstructive Cardiomyopathy
Scientific Title:Acronym
Bisoprolol Transdermal Patch for HOCM
Region
| Japan |
Condition
Condition
Hypertrophic obstructive cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the hemodynamic features of patients with HOCM who used the bisoprolol transdermal patch during perioperative care for non-cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic and echocardiographic features before and after patients switched from oral bisoprolol to transdermal patch therapy or started transdermal patch therapy as a new beta blocker medication
Key secondary outcomes
cardiovascular complications (all cause death, cardiac death, heart failure, ventricular tachycardia, and ventricular fibrillation) in the perioperative period
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
consecutive cases of HOCM with the patients using the bisoprolol transdermal patch during perioperative care
Key exclusion criteria
We excluded patients who exhibited only sigmoid septum but without significant hypertrophy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Imori |
Organization
Nippon Medical School
Division name
Department of Cardiovascular Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyoku,Tokyo 113-8603, Japan
TEL
03-3822-2131
s9012@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Imori |
Organization
Nippon Medial School Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyoku,Tokyo 113-8603, Japan
TEL
03-3822-2131
Homepage URL
s9012@nms.ac.jp
Sponsor or person
Institute
Nippon Medial School Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Medial School Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medial School Hospital
Address
1-1-5 Sendagi, Bunkyoku,Tokyo 113-8603, Japan
Tel
0338222131
s9012@nms.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 10 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients in the current study were retrospectively registered
Management information
Registered date
| 2019 | Year | 05 | Month | 10 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
