EUCTR2007-003558-27-CZ进行中（未招募）不适用
Addition of spironolactone in patients with resistant arterial hypertension (ASPIRANT) - ASPIRANT
Olomouc University Hospital and Palacký University School of Medicine, Internal Medicine Dept. I0 个研究点目标入组 160 人开始时间: 2007年7月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Only patients with resistant hypertension aged over 18 years will be enrolled.
- •Resistant hypertension is defined as blood pressure during clinical control exceeding 140/90 mmHg (average of 2nd and 3rd measurement during one visit, with at least 3-5 minutes between separate measurements) despite adherence to treatment with full doses of at least three antihypertensive medications, including a diuretic.
- •In diabetic patients or in patients with renal disease (i.e., with a creatinine level of more than 133 µmol per liter or urinary protein excretion of more than 300 mg over a 24-hour period) a blood pressure over 130/80 mmHg despite adherence to treatment with full doses of at least three antihypertensive medications including a diuretic is considered to be resistant.
- •Patients will sign informed consent before enrollment to the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Following patients will not be enrolled: patients with grade 3 hypertension (systolic BP over 180 mmHg and/or diastolic over 110 mmHg) who need immediate treatment; patients with renal failure (acute or chronic) with creatinine exceeding 180 umol/l or glomerular filtration below 40 ml/min (based on MDRD calculation), hyperkalemia over 5,4 mmol/l, hyponatremia below 130 mmol/l, porphyria, hypersensitivity to components of the drug Verospiron (Richter Gedeon, Hungary), women in gravidity or lactation period or women in productive age not using any of contraceptive methods, and patients who already use any of the aldosterone antagonists (spironolactone, epleronone, kanreone).
研究者
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