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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046613
Receipt No. 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 2022/01/19

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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
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 SGLT-2 inhibitor
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
Email 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
Email morio.ono@gmail.com

Sponsor
Institute Cardiology University Northern Yokohama Hospital
Institute
Department

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
Email 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 01 Month 19 Day


Link to view the page
URL(English) 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


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