Clinical study using spironolactone for hypertensive patients with type 2 diabetes and albuminuria

Tohoku University0 个研究点目标入组 140 人开始时间: 2013年5月23日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Type 2 diabetes (outpatient)
•2.Age at informed consent: 20 to 79 years old
•3.Hypertension treated with a fixed dose of ARB or ACEI for more than 3 months at informed consent
•4.Urinary albumin-to-creatinine ratios (UACR) in the first morning urine: >= 45 mg/gCr and <1000 mg/gCr at the last two time points before registration
•5.Office blood-pressure (seating position): 130 mmHg =< systolic-blood-pressure < 150 mmHg and 50 mmHg =< diastolic blood pressure < 95 mmHg at the last two time points before registration

•1.Type 1 diabetes
•2.History of treatment by MR antagonist (potassium sparing diuretics) within one year before informed consent.
•3.History of treatment by renin inhibitor within three months before informed consent.
•4.HbA1c: >= 8.4% (NGSP) at the last before registration.
•5.BMI: >= 35 at the last before registration
•6.Renovascular hypertension, bilateral or unilateral renal artery stenosis, renal artery stenosis with unilateral kidney.
•7.Progressive decline of renal function and it may result in an end-stage renal disease during the study.
•8.eGFR: <45 mL/min/1.73 m2 at the last before registration
•9.Serum potassium: >=5.0 mEq/L at the last before registration
•10.Uric acid: >=9.0 mg/dl at the last before registration
•11.History of acute coronary syndrome (ACS), percutaneous coronary-arteries intervention (PCI), coronary-artery bypass surgery (CABG), stroke, the transient ischemic attack (TIA) and revascularization of the carotid artery or the peripheral artery within 6 months before registration
•12.Heart failure classified into NYHA III or IV.
•13.The malignant tumor.
•14.Serious liver disease (hepatic insufficiency, liver cirrhosis, etc.).
•15.Pregnancy, possible to be pregnant or willing to be pregnant and lactation.
•16.Patients with contraindication to study drugs.
•17.Patients with a plan of treatment by tacrolimus or mitotan
•18.Patients considered to be inappropriate by investigator

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