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
CRIS Registration Number |
KCT0006055 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Hanmi Pharm |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Inha University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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 |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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