Clinical trial NCT02417571: Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of CKD
Official title: Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Renal Insufficiency, Chronic
Albuminuria
Hypertension
Keywords: Chronic kidney disease
Blood pressure
ambulatory blood pressure
glomerular filtration rate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Kangbuk Samsung Hospital
name: Severance Hospital
name: Eulji General Hospital
First posted: 2015-04-15
Enrollment: 188
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of estimated GFR decline
timeFrame: 18 months
Secondary outcomes:
measure: Renal events
timeFrame: 18 months
measure: Albuminuria
timeFrame: 18 months
measure: CV events
timeFrame: 18 months
measure: All-cause mortality
timeFrame: 18 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
References:
citation: 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.
citation: 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.