UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046613 |
|---|---|
| Receipt number | R000053175 |
| Scientific Title | Prospective randomized trial of angiotensin receptor neprilysin inhibitor addition after ablation for atrial fibrillation with hypertension |
| Date of disclosure of the study information | 2022/01/13 |
| Last modified on | 2022/02/16 10:15:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective randomized trial of angiotensin receptor neprilysin inhibitor addition after ablation for atrial fibrillation with hypertension
Acronym
Prospective randomized trial of angiotensin receptor neprilysin inhibitor addition after ablation for atrial fibrillation with hypertension
Scientific Title
Prospective randomized trial of angiotensin receptor neprilysin inhibitor addition after ablation for atrial fibrillation with hypertension
Scientific Title:Acronym
Prospective randomized trial of angiotensin receptor neprilysin inhibitor addition after ablation for atrial fibrillation with hypertension
Region
| Japan |
Condition
Condition
Atrial Fibrillation with hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare whether changing hypertension treatment to angiotensin receptor neprilysin inhibitor after ablation is superior to conventional hypertension treatment in maintaining sinus rhythm.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is recurrence of atrial fibrillation at 12-month after catheter ablation.
Key secondary outcomes
1) Atrial fibrillation recurrence rate (1,3,6,12 months after surgery)
2) Change in resting heart rate from baseline (1,3,6,12 months after surgery)
3) Changes in systolic and diastolic blood pressure from baseline (1, 3, 6, 12 months after surgery)
4) Amount of change from baseline in the following biochemical tests (3,6,12 months after surgery)
Triglyceride, LDL / HDL cholesterol, fatty acid 4 fraction, hemoglobin, hematocrit, cystatin C, renin, aldosterone, Brain natriuretic peptide, Atrial natriuretic peptide, Nt-proBNP, galectin3
5) Amount of change from baseline in the following echocardiographic findings (3,12 months after surgery)
Left atrium function: Booster function, Reservoir function, Conduit function, Atrial ejection force
Left atrium diameter, left atrium volume
Left ventricular expandability: E / e` ratio
Left ventricular ejection fraction (LVEF)
Velocity time integral (VTI)
6) Moyamoya echo, left atrial appendage blood flow velocity (within 48 hours before catheter ablation)
7)ratio of low potential region in the left atrium (during catheter ablation) in 2nd ablation at the time of recurrence (during catheter ablation)
8) Change in cardiothoracic ratio from baseline by chest X-ray (12 months after surgery)
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the intervention group, the antihypertensive drug is changed to an angiotensin receptor neprilysin inhibitor (ARNI) after ablation treatment.
Interventions/Control_2
The control group will continue with conventional antihypertensive drugs after ablation treatment.
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
Atrial fibrillation in patients with hypertension who undergo catheter ablation for atrial fibrillation.
All patients are treated with oral anti-coagulants before the procedure.
Key exclusion criteria
Patients who are intolerant for ARNI
Patients with renal insufficiency (estimated GFR < 30)
Patients with systolic blood pressure <100 mmHg
When the attending physician consider inappropriate to enroll the patient in the study
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
(+81)45-949-7000
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
(+81)45-949-7000
Homepage URL
morio.ono@gmail.com
Sponsor or person
Institute
Cardiology University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
(+81)45-949-7000
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 | 01 | Month | 13 | 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 | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 12 | Day |
Last modified on
| 2022 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053175
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
