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| Name | Class |
|---|---|
| Kangbuk Samsung Hospital | OTHER |
| Severance Hospital | OTHER |
| Eulji General Hospital | OTHER |
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Control of blood pressure (BP) is the first thing to do in the management of chronic kidney disease (CKD). Although guidelines suggest the optimal blood pressure level, it is hard to assess BP correctly during the office visit. Often there is a discrepancy between office BP and out-of-office BP, including home BP and ambulatory BP. Recent study reported that as many as 34% of Korean CKD patients had masked hypertension, which means high BP by ambulatory BP monitoring but normal BP by conventional office BP measurement.
This study aims to evaluate the effect of ambulatory BP-guided BP management on the clinical outcome of CKD, compared to the conventional management using office BP.
We hypothesized that management of blood pressure using ambulatory BP monitoring would obtain more optimal BP control and thereby would influence positively on renal progression and CV outcomes.
In detail, when the eligibility criteria is met, all the subjects will undergo both ambulatory BP and office BP measurement at baseline.
After randomization, ARB (fimasartan) will be administered to drug-naive subjects or will replace the other RAS blockers in subjects with current uses. Dosing of fimasartan will be adjusted or additional drugs of other classes will be added sequentially over 3 months (titration phase).
At 3 months, ABPM will be performed in ABPM group to evaluate the adequacy of blood pressure control and dosing will be adjusted according to the ABPM results (target BP: daytime BP < 135/85 mm Hg). This adjustment will be assessed at 6 months by ABPM once again.
For subjects in office BP group, conventional care will be provided according to current guidelines (target BP < 140/90 mm Hg).
At 18 months, ABPM will be performed in all the subjects and outcome measures will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABPM group | Experimental | Ambulatory blood pressure monitoring (ABPM) performed at 3, 6 months after randomization; adjusting drugs/doses based on ABPM results. Target BP: daytime ABP < 135/85 mm Hg according to British NICE clinical guideline 127. |
|
| Office BP group | No Intervention | Conventional BP management using office BP according to KDIGO guideline on BP management. Target BP: <140/90 mm Hg. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory blood pressure monitoring (ABPM) | Device | 24-hour ambulatory BP monitoring using TM-2430 device (A&D Company, Tokyo, Japan) |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of estimated GFR decline | annual decline of eGFR over 18 months | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Renal events | dialysis, transplantation, doubling of serum creatinine or >50% decline of eGFR | 18 months |
| Albuminuria | change of urine albumin-to-creatinine ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eulji General Hospital | Seoul | South Korea | ||||
| Kangbuk Samsung Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24048482 | Background | Cha RH, Kim S, Ae Yoon S, Ryu DR, Eun Oh J, Han SY, Young Lee E, Ki Kim D, Kim YS. Association between blood pressure and target organ damage in patients with chronic kidney disease and hypertension: results of the APrODiTe study. Hypertens Res. 2014 Feb;37(2):172-8. doi: 10.1038/hr.2013.127. Epub 2013 Sep 19. | |
| 38088422 | Derived |
| Label | URL |
|---|---|
| 2012 KDIGO Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease | View source |
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| 18 months |
| CV events | Cardiovascular deaths, nonfatal myocardial infarction, admission due to aggravation of CHF, or revascularization (CABG or PCI) | 18 months |
| All-cause mortality | 18 months |
| Seoul |
| South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Yonsei University Severance Hospital | Seoul | South Korea |
| Kim Y, Kim J, Kang E, Im DW, Kim T, Huh H, Kim YH, Lee H, Kim JH, Oh KH. The association of time-updated ambulatory blood pressure and renal progression in hypertensive patients with chronic kidney disease: post hoc analysis of ACCURATE study. J Hypertens. 2024 Mar 1;42(3):515-520. doi: 10.1097/HJH.0000000000003625. Epub 2023 Dec 6. |
| 33031169 | Derived | Kim Y, Kim J, Lee SW, Sung S, Yoo TH, Lee KB, Hwang YH, Kim T, Kang SW, Kim YH, Oh KH. Effect of ambulatory blood pressure monitoring guided antihypertensive treatment on renal progression in patients with chronic kidney disease: a randomized comparative study. J Hypertens. 2021 Feb 1;39(2):325-332. doi: 10.1097/HJH.0000000000002624. |
| British NICE guideline 127: Hypertension: clinical management of primary hypertension in adults | View source |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000419 | Albuminuria |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D018660 | Blood Pressure Monitoring, Ambulatory |
| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
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