Hypertensive patients with chronic kidney disease that enough hypotensive effect is not obtained with an angiotensin receptor blocker
Conditions
Interventions
Eplerenone (50mg/day) is added in patients under treatment of angiotensin receptor blocker (ARB). If blood pressure dose not reach to lower than 130/80mmHg, other antihypertensive drug except ARB, epl
Sponsors
OWASE study Project Office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Among the following, the patient satisfying all the conditions from 1 to 4 becomes a subject. 1. Urinary albumin/creatinine ratio is more than 10mg/gCr 2. Though angiotensin receptor blocker has been administered for more than 3 months, systolic blood pressure is equal or more than 130mmHg or diastolic blood pressure is equal or more than 80mmHg (in patients developing that urinary protein is equal or more than 1g/day, systolic blood pressure 125mmHg or diastolic blood pressure is qual or more than 75mmHg) 3. Age is equal or more than 20 4. Patients who have given written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypertension (systolic blood pressure is equal or more 220 mmHg, or diastolic blood pressure is equal or more 110 mmHg) 2. Unstable angina pectoris 3. Myocardial infarction occurs within 6 months 4. Severe heart failure (NYHA class is equal or more than III) 5. Severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyarrhythmia, atrial fibrillation, atrial flutter, sick sinus syndrome or atrio-ventricular block) 6. eGFR is less than 36mL/min/1.73m2 7. Severe liver dysfunction or Child-Pugh class score is C 8. Active cancer 9. Serum potassium is equal or more than 5 mEq/L 10. Diabetic patients with microalbuminuria (urinary albumin/creatinine ratio is equal or more than 30mg/gCr) or proteinuria 11. Supplementation of K or administration of K-sparing diuretics 12. Administration of itraconazole, ritonavir or nelfinavir 13. Administration of steroid or immunosuppressant 14. Pregnant, possible to be pregnant 15. Patient who is already treated for study drugs 16. Patients with allergy or contraindication to study drugs 17. Patients that it is impossible to get an agreement 18. Patients who are inadequate by determination of physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in urinary albumin/creatinine ratio from pretreatment period to 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in office blood pressure 2. Change in estimated glomerular filtration rate (eGFR) 3. Change in urinary protein 4. Change in brachial-ankle pulse wave velocity (baPWV) 5. Change in BNP 6. Change in cardiac ultrasonography findings (ejection fraction, E', A', E/E', left ventricukar mass) 7. Cerebro-cardio-vascular events (all death, non-fatal myocardial infarction, angina pectoris, stroke, heart failure) 8. Side effect of eplerenone or thiazide diuretics | — |
Countries
Japan
Contacts
Public ContactMashio Nakamura
Mie University Graduate School of Medicine Department of Cardiology and Nephrology
Outcome results
None listed