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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02417571

Collaborator

Kangbuk Samsung Hospital (Other), Severance Hospital (Other), Eulji General Hospital (Other)

188

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Renal Insufficiency, Chronic Albuminuria Hypertension	Device: Ambulatory blood pressure monitoring (ABPM)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

rate of estimated GFR decline [18 months]
annual decline of eGFR over 18 months

Secondary Outcome Measures

Renal events [18 months]
dialysis, transplantation, doubling of serum creatinine or >50% decline of eGFR
Albuminuria [18 months]
change of urine albumin-to-creatinine ratio
CV events [18 months]
Cardiovascular deaths, nonfatal myocardial infarction, admission due to aggravation of CHF, or revascularization (CABG or PCI)
All-cause mortality [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Eulji General Hospital	Seoul	Korea, Republic of
2	Kangbuk Samsung Medical Center	Seoul	Korea, Republic of
3	Seoul National University Hospital	Seoul	Korea, Republic of
4	Yonsei University Severance Hospital	Seoul	Korea, Republic of