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

Hypertension Clinical Trial

— ACCURATE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02417571
• Other study ID #: BR-ABPM
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2019

Study information

• Verified date: June 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Albuminuria
• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Ambulatory blood pressure monitoring (ABPM)
24-hour ambulatory BP monitoring using TM-2430 device (A&D Company, Tokyo, Japan)

Locations

Country	Name	City	State
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	Yonsei University Severance Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Eulji General Hospital, Kangbuk Samsung Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of estimated GFR decline	annual decline of eGFR over 18 months	18 months
Secondary	Renal events	dialysis, transplantation, doubling of serum creatinine or >50% decline of eGFR	18 months
Secondary	Albuminuria	change of urine albumin-to-creatinine ratio	18 months
Secondary	CV events	Cardiovascular deaths, nonfatal myocardial infarction, admission due to aggravation of CHF, or revascularization (CABG or PCI)	18 months
Secondary	All-cause mortality		18 months

External Links

•   2012 KDIGO Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease
•   British NICE guideline 127: Hypertension: clinical management of primary hypertension in adults