UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049953 |
|---|---|
| Receipt number | R000056893 |
| Scientific Title | The Impact of sacubitril/valsartan on atrial fibrillation in hypertensive patients with cardiac implantable electronic devices |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/07/03 18:16:34 |
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Basic information
Public title
The Impact of sacubitril/valsartan on atrial fibrillation in hypertensive patients with cardiac implantable electronic devices
Acronym
The Impact of sacubitril/valsartan on atrial fibrillation in hypertensive patients with cardiac implantable electronic devices
Scientific Title
The Impact of sacubitril/valsartan on atrial fibrillation in hypertensive patients with cardiac implantable electronic devices
Scientific Title:Acronym
The Impact of sacubitril/valsartan on atrial fibrillation in hypertensive patients with cardiac implantable electronic devices
Region
| Japan |
Condition
Condition
Hypertension and Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether sacubitril-valsartan suppresses atrial fibrillation by evaluating atrial high-rate episodes detected by the cardiac implantable electronic device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number, duration, and total duration of atrial high-rate episodes
Key secondary outcomes
Echocardiography measurements, NT-proBNP(N-terminal pro-brain natriuretic peptide
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
200 mg of sacubitril/valsartan is orally administered once daily. The dose may be adjusted according to age and symptoms, but the maximum dose is 400 mg once a day.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients more than 6 months after cardiac implantable electronic device implantation who have had a cardiac implantable electronic device detected atrial high-rate episodes within 6 months
Key exclusion criteria
Patients with sacubitril/valsartan contraindications, patients with chronic atrial fibrillation, patients with eGFR 30 mL/min/1.73 m2 or less, patients with systolic blood pressure less than 100 mmHg
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takanao |
| Middle name | |
| Last name | Mine |
Organization
Hyogo Medical University
Division name
Department of Advanced Therapeutics for Cardiac Disease
Zip code
6638501
Address
1-1, Mukogawa-cyo, Nishinomiya, Japan
TEL
+81798456111
mine@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takanao |
| Middle name | |
| Last name | Mine |
Organization
Hyogo Medical University
Division name
Department of Cardiovascular and Renal Medicine
Zip code
6638501
Address
1-1, Mukogawa-cyo, Nishinomiya, Japan
TEL
+81798456552
Homepage URL
mine@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
others
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
Hyogo Medical University
Address
1-1, Mukogawa-cyo, Nishinomiya, Japan
Tel
+81798456111
mine@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 02 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056893
| Research Plan | |
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| 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 |
