Chronic Kidney DiseasesACCURATENCT02417571
Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of CKD
A study testing Ambulatory blood pressure monitoring (ABPM) in people with Chronic Kidney Diseases and Renal Insufficiency, Chronic, run by Seoul National University Hospital at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Chronic Kidney Diseases, Renal Insufficiency, Chronic, Albuminuria
- What is being tested?
- Ambulatory blood pressure monitoring (ABPM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Apr 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Contraindication to renin-angiotensin system blockers (hypersensitivity, bilateral renal artery stenosis, single kidney, etc.)
- Pregnancy
- Kidney recipients
- Participating other clinical trials, except observational studies
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Eulji General Hospital
Seoul
Kangbuk Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Yonsei University Severance Hospital
Seoul
About this study
Official title: 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.
Read the 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.
- Being tested
- Ambulatory blood pressure monitoring (ABPM)
- Keywords
- Chronic kidney disease, Blood pressure, ambulatory blood pressure, glomerular filtration rate
- Medical subject headings
- Renal Insufficiency, Chronic, Albuminuria, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory blood pressure monitoring (ABPM)Device
24-hour ambulatory BP monitoring using TM-2430 device (A\&D Company, Tokyo, Japan)
| Study group | Role | What they receive |
|---|---|---|
| ABPM group | Experimental | 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. Receives: Device: Ambulatory blood pressure monitoring (ABPM) |
| Office BP group | No intervention | Conventional BP management using office BP according to KDIGO guideline on BP management. Target BP: <140/90 mm Hg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of estimated GFR decline
annual decline of eGFR over 18 months
Measured: 18 months
Secondary outcomes (4)
Renal events
dialysis, transplantation, doubling of serum creatinine or >50% decline of eGFR
Measured: 18 months
Albuminuria
change of urine albumin-to-creatinine ratio
Measured: 18 months
CV events
Cardiovascular deaths, nonfatal myocardial infarction, admission due to aggravation of CHF, or revascularization (CABG or PCI)
Measured: 18 months
All-cause mortality
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kangbuk Samsung Hospital, Severance Hospital, Eulji General Hospital
- Responsible party
- Principal investigator, Kook-Hwan Oh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417571
- Sponsor's protocol ID
- BR-ABPM
- Acronym
- ACCURATE
- Status last verified
- Jun 2019
- First submitted
- 11 Apr 2015
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24048482Kim 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.
PubMed 38088422Kim 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.
PubMed 33031169
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02417571
- Acronym / sponsor ID
- ACCURATE / BR-ABPM
- Keywords
- Chronic kidney disease, Blood pressure, ambulatory blood pressure, glomerular filtration rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Kangbuk Samsung Hospital, Severance Hospital, Eulji General Hospital
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABPM group | Experimental | Device: 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. |
| Office BP group | No intervention | –Conventional BP management using office BP according to KDIGO guideline on BP management. Target BP: <140/90 mm Hg. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory blood pressure monitoring (ABPM)24-hour ambulatory BP monitoring using TM-2430 device (A\&D Company, Tokyo, Japan) | Device | ABPM group |
Primary outcome
rate of estimated GFR decline
Time frame: 18 months
annual decline of eGFR over 18 months
4 secondary outcomes
Renal events
Time frame: 18 months
Albuminuria
Time frame: 18 months
CV events
Time frame: 18 months
All-cause mortality
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Background: PubMed 24048482Cha 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.
- Derived from this study: PubMed 38088422Kim 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.
- Derived from this study: PubMed 33031169Kim 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.
- 2012 KDIGO Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney DiseaseLink provided by the sponsor.
- British NICE guideline 127: Hypertension: clinical management of primary hypertension in adultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory blood pressure monitoring (ABPM) in people with Chronic Kidney Diseases and Renal Insufficiency, Chronic, run by Seoul National University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of estimated GFR decline (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417571, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.