Effects of combination therapy with efonidipine or cilnidipine added on ARB on renal outcomes in hypertensive patients with CKD and proteinuria
- Conditions
- Hypertension with chronic kidney disease
- Registration Number
- JPRN-UMIN000005359
- Lead Sponsor
- Shinshu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 250
Not provided
(1) Patients who are younger than 20 or older than 80 years. (2) Patients who have renovascular hypertension, primary aldosteronism, Cushing's disease, or pheochromocytoma (3) Patients who had transient ischemic attack or apoplexy within six months prior to enrollment (4) Patients who had unstable angina, acute myocardial infarction, or underwent coronary artery bypass graft or percutaneous coronary intervention within six months prior to enrollment. (5) Patients who have congestive heart failure of NYHA class II or higher (6) Patients who have dissection of aorta or occlusive arterial disease (7) Patients who have HbA1c > 9.0% or uncontrolled diabetes mellitus (8) Patients who are pregnant or have possibility of pregnancy (9) Patients whose levels of AST or ALT are more than 2 times higher than upper normal limits (10) Patients who had nephrotic syndrome within one year prior to enrollment or have nephrotic syndrome (11) Patients who have malignant diseases or collagen diseases (12) Patients in whom irbesartan is contraindicated (13) Patients in whom efonidipine is contraindicated (14) Patients in whom cilnidipine is contraindicated (15) Patients who have previous history of allergy to an ARB or CCB (16) Patients who are taking another hypertensive drug together with an ARB at maximum dosing (17) Patients who were deemed not appropriate to participate in this study by doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Change in aldosterone (2) Change in proteinuria (3) Change in eGFR
- Secondary Outcome Measures
Name Time Method Change before and after treatment of the following items: (1) BNP and hs-CRP (2) Urinary 8-OHdG