Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of CKD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of Chronic Kidney Disease

Conditions
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Chronic Kidney Diseases, Renal Insufficiency, Chronic, Albuminuria, Hypertension

Intervention / Treatment
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* Device: Ambulatory blood pressure monitoring (ABPM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Office BP > 130/80 mm Hg, irrespective of anti-hypertensive medication CKD stages 3-4 (or estimated GFR 15-59 ml/min per 1.73 m2) Random urine albumin-to-creatinine ratio > 300 mg/g or protein-to-creatinine ration > 300 mg/g or dipstick albumin > 1+, in case of estimated GFR 45-59 ml/min per 1.73 m2 Exclusion Criteria: Systolic BP > 180 mm Hg or diastolic BP > 110 mm Hg Malignant hypertension Resistant hypertension (using more than three kind of anti-hypertensive drugs other than diuretics) Uncontrolled DM (Hb A1c > 10.0% within 3 months of eligibility assessment) Use of immunosuppressive agents within 1 months or anticipated Atrial fibrillation or flutter Contraindication to renin-angiotensin system blockers (hypersensitivity, bilateral renal artery stenosis, single kidney, etc.) Pregnancy Kidney recipients Participating other clinical trials, except observational studies

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABPM group<br>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. | Device: Ambulatory blood pressure monitoring (ABPM)<br>* 24-hour ambulatory BP monitoring using TM-2430 device (A&D Company, Tokyo, Japan)<br>|
| No Intervention: Office BP group<br>Conventional BP management using office BP according to KDIGO guideline on BP management. Target BP: <140/90 mm Hg. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of estimated GFR decline | annual decline of eGFR over 18 months | 18 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Blood pressure, ambulatory blood pressure, glomerular filtration rate