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Clinical Impact of Blood Pressure Control on Clinical Outcome in Atrial fibrillation Patients with Hypertension

Status Approved

  • First Submitted Date

    2021/03/24

  • Registered Date

    2021/04/05

  • Last Updated Date

    2021/03/24

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006055
    Unique Protocol ID 2020-12-007
    Public/Brief Title Clinical Impact of Blood Pressure Control on Clinical Outcome in Atrial fibrillation Patients with Hypertension
    Scientific Title Clinical Impact of Blood Pressure Control on Clinical Outcome in Atrial fibrillation Patients with Hypertension
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2020-12-007
    Approval Date 2021-02-15
    Institutional Review Board Name institutional review board of Inha University Hospital
    Institutional Review Board Address 27, Inhang-ro, Jung-gu, Incheon
    Institutional Review Board Telephone 032-890-3691
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Baek Yong Soo
    Title professor
    Telephone +82-32-890-2440
    Affiliation Inha University
    Address 27, Inhang-ro, Jung-gu, Incheon
    Contact Person for Public Queries
    Name Kim Yu Jeong
    Title CRC
    Telephone +82-32-890-2555
    Affiliation Inha University Hospital
    Address 27, Inhang-ro, Jung-gu, Incheon
    Contact Person for Updating Information
    Name Kim Yu Jeong
    Title CRC
    Telephone +82-32-890-2555
    Affiliation Inha University Hospital
    Address 27, Inhang-ro, Jung-gu, Incheon
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-05-03 Anticipated
    Target Number of Participant 250
    Primary Completion Date 2024-02-28 , Anticipated
    Study Completion Date 2024-03-29 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Inha University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-05-03 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Hanmi Pharm
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Inha University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Based on recent research such as the RACE 3 trial, the European Heart Association atrial fibrillation (AF) guidelines include correction of unhealthy lifestyle habits and strict blood pressure control (less than 120/80mmHg) to improve the  AF burden and symptoms. Targeted treatment is recommended. The 2018 European Society of Cardiology/Hypertension found that when diuretics are used to treat hypertension, thiazide-like diuretics such as chlorthalidone have a greater effect on lowering blood pressure longer action time than hydrochlorothiazide. There are also reports that one-time chlorthalidone diuretics are expected to play a role as a blood pressure drug to prevent heart failure. In this respect, in addition to medication for atrial fibrillation, management of blood pressure for hypertension is expected to not only improve the quality of life for patients with AF but also significantly affect the prognosis. There is still little research on the effect of active combination therapy on blood pressure control in patients with atrial fibrillation, the recurrence of atrial fibrillation, quality of life, and further prognosis. This study is a combination therapy for atrial fibrillation patients with hypertension. How much the active treatment of the back affects blood pressure control, and the clinical effect of it is compared and analyzed. Through this, it is expected that it will not only present the actual basis for the existing guidelines for atrial fibrillation in Korea but also as a guideline for the management of patients with atrial fibrillation with high blood pressure in actual clinical practice.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    -Intensive BP treatment:
    
    
    
    
    Antihypertensive drug (renin-angiotensin system blocker + calcium channel antagonist + long-acting time diuretic (chlorthalidone) combined therapy with the single-pill (SPC)) therapy was used to measure target blood pressure during the follow-up period, on average 120 / Group adjusted to less than 90mmHg
    
    
    
    
    -General blood pressure control group (standard BP treatment):
    
    
    
    
    Renin-angiotensin system blockers (Angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB)), calcium channel antagonists, and other general antihypertensive drugs were used to control the target blood pressure to an average of less than 140/90mmHg during the follow-up period. group
    Number of Arms 2
    Arm 1

    Arm Label

    intensive BP treatment

    Target Number of Participant

    125

    Arm Type

    Experimental

    Arm Description

    Antihypertensive drug (renin-angiotensin system blocker + calcium channel antagonist + long-acting time diuretic (chlorothalidone) combined therapy with single pill (SPC)) therapy was used to measure target blood pressure during follow-up period, on average 120 / Group adjusted to less than 90mmHg.
    According to each blood pressure target, antihypertensive drugs and atrial fibrillation treatment were performed, clinical follow-up was performed at 3, 6, and 9 months, and active blood pressure monitoring was performed at 12 months.
    In both the active blood pressure control group and the general blood pressure treatment group, the treatment of patients is performed according to standard treatment procedures in the treatment underlying hypertension and atrial fibrillation.
    Arm 2

    Arm Label

    standard BP treatment

    Target Number of Participant

    125

    Arm Type

    Active comparator

    Arm Description

    Renin-angiotensin system blocker (Angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB)), calcium channel antagonist, etc. group.
    According to each blood pressure target, antihypertensive drugs and atrial fibrillation treatment were performed, clinical follow-up was performed at 3, 6, and 9 months, and active blood pressure monitoring was performed at 12 months.
    In both the active blood pressure control group and the general blood pressure treatment group, the treatment of patients is performed according to standard treatment procedures in the treatment underlying hypertension and atrial fibrillation.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I11.9)Hypertensive heart disease without (congestive) heart failure 

    Patients with atrial fibrillation with hypertension
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    ① Patients aged 19 or older with non-membrane atrial fibrillation
    ② Patients with hypertension who need medication
    *Patients with hypertension who require drug treatment currently follow the guidelines for hypertension treatment of the Korean Society of Hypertension in 2018.
    ③ Patients who have not previously taken antihypertensive drugs
    ④ Patients who agree with the purpose of this study
    Exclusion Criteria
    ① Atrial fibrillation accompanied by severe heart malformation or structural heart disease affected by hemodynamics
    ② Severe renal dysfunction
    ③ Patients with a history of atrial fibrillation high frequency electrode catheter resection or labyrinth surgery
    ④ Patients with significant mitral valve stenosis (moderate or higher)
    ⑤ Patients with active internal bleeding
    ⑥ Patients diagnosed with hypertrophic cardiomyopathy
    ⑦ Polycystic kidney disease
    ⑧ Significant comorbid disease
    ⑨ Patients whose survival period is expected to be less than 1 year
    ⑩ Patients with drug or alcohol addiction
    ⑪ Patients diagnosed with stroke within the last 3 months
    ⑫ Patients judged unsuitable for participation in clinical trials by the judgment of other researchers
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    After the normal sinus rhythm, the patient included in the RCT was analyzed using the retention rate and intention to treat analysis.Including interim analysis of patients who followed up for more than 30 days using per-protocol analysis.
    Timepoint
    3, 6, 9 months
    Secondary Outcome(s) 1
    Outcome
    -Blood pressure control (average of self-monitoring blood pressure, average of 24-hour active blood pressure monitoring)-Assessment of the incidence of cerebral infarction, hospitalization, cardiovascular events, mortality, and quality of life (SF-36)
    Timepoint
    Conduct 3, 6, 9 months and monitor active blood pressure at 12 months
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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