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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-12-31

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.

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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.

Conditions

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Chronic Kidney Diseases Renal Insufficiency, Chronic Albuminuria Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABPM group

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.

Group Type EXPERIMENTAL

Ambulatory blood pressure monitoring (ABPM)

Intervention Type DEVICE

24-hour ambulatory BP monitoring using TM-2430 device (A\&D Company, Tokyo, Japan)

Office BP group

Conventional BP management using office BP according to KDIGO guideline on BP management.

Target BP: \<140/90 mm Hg.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ambulatory blood pressure monitoring (ABPM)

24-hour ambulatory BP monitoring using TM-2430 device (A\&D Company, Tokyo, Japan)

Intervention Type DEVICE

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No