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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Chronic Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria
• Intervention / Treatment: Device: Ambulatory blood pressure monitoring (ABPM)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Eulji General Hospital
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Medical Center
  • Seoul, Korea, Republic of
    • Yonsei University Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Kangbuk Samsung Hospital; Severance Hospital; Eulji General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• 2012 KDIGO Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease
• British NICE guideline 127: Hypertension: clinical management of primary hypertension in adults

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 11, 2015
• First Submitted That Met QC Criteria: April 11, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Blood pressure; Chronic kidney disease; glomerular filtration rate; ambulatory blood pressure
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Proteinuria; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Albuminuria
• Other Study ID Numbers: BR-ABPM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No