UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048443 |
|---|---|
| Receipt number | R000055207 |
| Scientific Title | Observational study of patients with angiotensin receptor neprilysin inhibitor pacemaker |
| Date of disclosure of the study information | 2022/07/28 |
| Last modified on | 2022/07/24 09:51:54 |
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Basic information
Public title
Observational study of patients with angiotensin receptor neprilysin inhibitor pacemaker
Acronym
Observational study of patients with angiotensin receptor neprilysin inhibitor pacemaker
Scientific Title
Observational study of patients with angiotensin receptor neprilysin inhibitor pacemaker
Scientific Title:Acronym
Observational study of patients with angiotensin receptor neprilysin inhibitor pacemaker
Region
| Japan |
Condition
Condition
HT Af
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Since non-physiological pacing after pacemaker implantation causes progressive myocardial fibrosis and increased incidence of atrial fibrillation, we will track the time to onset of atrial fibrillation, electrical parameters, and blood tests in patients with pacemaker implantation complicated with hypertension who are switched to ARNI on oral antihypertensive medications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to atrial fibrillation onset
Key secondary outcomes
Atrial fibrillation 6, 12, 18, 24 months after surgery
Change in parameters
AP VP battery voltage A, Vlead resistance, threshold, wave height AFburden at 24 months after pacemaker implantation
Total number of supraventricular extrasystoles Supraventricular extrasystoles short run atrial tachycardia 6,12,18,24 months after surgery
Change from baseline in resting heart rate 6, 12, 18, and 24 months after surgery
Change from baseline in the following biochemical tests 6,12,18,24 months after surgery
Neutral fat, LDL,HDL cholesterol, fatty acid quartiles, hemoglobin, hematocrit, cystatin C, renin, aldosterone, Brain natriuretic peptide, Atrial natriuretic peptide, NT-pro BNP
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HT
After pacemaker implantation
Key exclusion criteria
(1) When the research subject requests discontinuation.
(2) When the research is interrupted for reasons attributable to the research subject (e.g., moving, changing doctors or hospitals, busy schedule, inability to follow up, etc.)
(3) When it is found that the research subject is not a target case after the research has begun.
(4) In the event of an accidental incident
(5) When an adverse event occurs (including exacerbation of the underlying disease, complications, or accident) and the investigator determines that the study should be terminated
(6) When it becomes difficult to continue the research due to inadequate efficacy or worsening of symptoms
(7) When there is a serious deviation from the research protocol and it is judged that the research cannot be evaluated
(8) When it is found that the research subject is not taking the medication as instructed by the physician in charge of the research
(9) Other cases in which the investigator determines that the continuation of the research is difficult and that discontinuation is appropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | morio |
| Middle name | |
| Last name | ono |
Organization
Showa University Northern Yokohama Hospital
Division name
Cardiology
Zip code
224-8503
Address
35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
TEL
0459497000
morio.ono@gmail.com
Public contact
Name of contact person
| 1st name | morio |
| Middle name | |
| Last name | ono |
Organization
Showa University Northern Yokohama Hospital
Division name
Cardiology
Zip code
224-8503
Address
35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
TEL
0459497000
Homepage URL
morio.ono@gmail.com
Sponsor or person
Institute
Department of Cardiology University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology University Northern Yokohama Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Cardiology University Northern Yokohama Hospital
Address
35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
Tel
09024661013
morio.ono@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 28 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2022 | Year | 07 | Month | 24 | Day |
Last modified on
| 2022 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055207
| 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 |
