Addition of Spironolactone in Patients With Resistant Arterial Hypertension
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of spironolactone on lowering blood pressure when added to therapy in patients with resistant arterial hypertension.
详细描述
Arterial hypertension resistant to therapy and requiring treatment with more then three antihypertensive drugs is common. At present there are is no standard therapy for resistant hypertension based on randomised clinical trials, neither data to guide addition of further drugs to therapy. Recently some observational and retrospective trials reported good effect of spironolactone in patients with resistant hypertension, but these data were not validated by prospective randomised clinical trials.
This is a multicentric, randomised, double blind clinical trial, which will evaluate the effect of addition of 25 mg spironolactone to current medication compared to placebo. The study will enroll patients with blood pressure over 140/90 mmHg during a clinical examination, which are using at least three antihypertensive drugs, one of them being a diuretic. Average daytime systolic and diastolic blodd pressure will be evaluated by ABPM (ambulatory blood pressure monitoring).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years
- •Resistant arterial hypertension: (blood pressure during clinical control exceeding 140/90 mmHg (or 130/80 mmHg in in diabetic patients or patients with renal disease with creatinine level of more than 133 μmol per liter or urinary protein excretion of more than 300 mg over a 24-hour period) despite adherence to treatment with full doses of at least three antihypertensive medications, including a diuretic
排除标准
- •Pregnant or breastfeeding women, women in fertile age without ruled out pregnancy
- •Severe hypertension over 180/110 mmHg
- •Renal insufficiency with creatinine over 180 umol/l or GFR lower than 40 ml/min
- •Hyperkalemia over 5,4 mmol/l, hyponatremia below 130 mmol/l
- •Porphyria
- •Hypersensitivity to the compounds of Verospiron (Richter Gedeon, Hungary) drug
- •Patients taking any aldosterone antagonist (spironolactone, eplerenone, kanreone)
研究组 & 干预措施
1
25 mg of Spironolactone oraly once daily
干预措施: spironolactone (Drug)
2
placebo oraly once daily
干预措施: spironolactone (Drug)
结局指标
主要结局
Average daytime systolic and diastolic blodd pressure evaluated by ABPM (ambulatory blood pressure monitoring)
时间窗: before and after 2 months of treatment
次要结局
- changes of serum potassium, natrium, creatinine, body weight, casual blood pressure in office, treatment response for different baseline levels of aldosterone and aldosterone/PRA ratio(2 months of follow-up)
研究者
Jan Vaclavík
Principal investigator
University Hospital Olomouc