Hypertension Clinical Trial
— ACCURATEOfficial title:
Effect of Ambulatory BP Monitoring on the CliniCal coUrse and RenAl ouTcomE of Chronic Kidney Disease
Verified date | June 2019 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Eulji General Hospital, Kangbuk Samsung Hospital, Severance Hospital |
Korea, Republic of,
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
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 |
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