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

Not Applicable

• Conditions: Chronic Kidney Diseases; Albuminuria; Hypertension; Renal Insufficiency, Chronic
• Interventions: Device: Ambulatory blood pressure monitoring (ABPM)

• Registration Number: NCT02417571
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-11
• Study First Submitted QC: 2015-04-11
• Study First Posted: 2015-04-15
• Primary Completion: 2018-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABPM group	Ambulatory blood pressure monitoring (ABPM)	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.

Primary Outcome Measures

Name	Time	Method
rate of estimated GFR decline	18 months	annual decline of eGFR over 18 months

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Eulji General Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of