Hypertensive patients with CKD under the treatment of the inhibitor of the renin-angiotensin system(RAS)
Conditions
Interventions
Azelnidipine(8 to 16mg/day) is added in patients with the treatment of the RAS inhibitor.If BP dose not reach to lower than 130/80mmHg, other antihypertensive drug except CCB, diuretic and RAS inhibit
Sponsors
Niigata University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients to fulfill all the following condition can participate 1) Outpatient systolic BP is equal or more than 130 and less than 180 and/or outpatient diastolic BP is equal or more than 85 and less than 110 mmHg. 2) Outpatients with CKD 3) eGFR is more than 30 mL/min/1.73m2. 4) Age is equal or more than 20 and less than 85 year-old. 5) RAS inhibitor has been administered for more than 3 months and CCB and diureteic have not been given within 3 months. 6) Written informed consent is obtained based on written and oral explanation of physician in charge.
Exclusion criteria
Exclusion criteria: 1) Secondary hypertension or malignant hypertension(within hypertension in level 3) 2) Severe heart failure(NYHA Class is equal or more than III) 3) Atrial fibrillation or flutter with severe arrhythmia 4) Severe renal failure or liver failure(patient on dialysis, AST or ALT is more than 5 times higher upper limits) 5) Not appropriate for change to the test drugs from current therapy for coronary disease(i.e. CCB, diuretics, etc.) 6) Patient with severe adverse effects by RAS inhibitor, CCB and diuretic 7) Patient has merged the disease seems to be bad, such as malignant tumor prognosis. 8) Type 1 diabetes and type 2 diabetes required hospitalization due to high hemoglobin A1c(equal and more than 9.0%), extremely high blood glucose, or diabetic ketoacidosis. 9) Patients already used other CCB or a diuretic. 10) Pregnant, possible to be pregnant, or willing to be pregnant 11) Patients who are inadequate by determination of physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in urinary albumin/creatinine(Alb/Cr) ratio in early morning samples from pretreatment period to 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. blood pressure(Office, Home) 2. Pulse rate(Home) 3. Change in the urinary Alb/Cr ratio 4. Change in eGFR 5. Relationship between BMI and BP/urinary Alb/Cr ratio 6. Change in HbA1c levels 7. Change in urinary excretion of sodium 8. Change in serum uric acid 9. Change in urinary megalin and urine podocalyxin 10. Cerebro-cardio-vascular events | — |
Countries
Japan
Contacts
Public ContactEmiko Kouno
Niigata University Graduate School of Medical and Dental Sciences Division of Clinical Nephrology and Rheumatology
Outcome results
None listed