Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of CKD
ACCURATE
1 other identifier
interventional
188
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 11, 2015
CompletedFirst Posted
Study publicly available on registry
April 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJune 5, 2019
June 1, 2019
3.7 years
April 11, 2015
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of estimated GFR decline
annual decline of eGFR over 18 months
18 months
Secondary Outcomes (4)
Renal events
18 months
Albuminuria
18 months
CV events
18 months
All-cause mortality
18 months
Study Arms (2)
ABPM group
EXPERIMENTALAmbulatory 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.
Office BP group
NO INTERVENTIONConventional BP management using office BP according to KDIGO guideline on BP management. Target BP: \<140/90 mm Hg.
Interventions
24-hour ambulatory BP monitoring using TM-2430 device (A\&D Company, Tokyo, Japan)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Kangbuk Samsung Hospitalcollaborator
- Severance Hospitalcollaborator
- Eulji General Hospitalcollaborator
Study Sites (4)
Eulji General Hospital
Seoul, South Korea
Kangbuk Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
Related Publications (3)
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.
PMID: 24048482BACKGROUNDKim Y, Kim J, Kang E, Im DW, Kim T, Huh H, Kim YH, Lee H, Kim JH, Oh KH. The association of time-updated ambulatory blood pressure and renal progression in hypertensive patients with chronic kidney disease: post hoc analysis of ACCURATE study. J Hypertens. 2024 Mar 1;42(3):515-520. doi: 10.1097/HJH.0000000000003625. Epub 2023 Dec 6.
PMID: 38088422DERIVEDKim 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.
PMID: 33031169DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor, Division of Nephrology, Department of Internal Medicine
Study Record Dates
First Submitted
April 11, 2015
First Posted
April 15, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
June 5, 2019
Record last verified: 2019-06