South Danish Hypertension and Diabetes Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 主要终点
- Change of of Systolic Blood Pressure
研究概览
简要总结
The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.
详细描述
The primary object of the study is to estimate the effect of addition of low dose spironolactone to antihypertensive treatment with at least three antihypertensive drugs in patients with type-2 diabetes and blood pressure over 130/80 mmHg.
Secondary aims are to estimate how many of these patients have their blood pressure controlled by the addition of spironolactone, to investigate whether the addition of spironolactone affects insulin sensitivity and urinary protein secretion and to estimate the incidence of adverse effects of the aldosterone antagonist.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 75 years
- •Type-2 diabetes
- •Therapy resistant hypertension (by ABPM)
- •Treatment with at least 3 antihypertensives
排除标准
- •HbA1c > 10.0
- •BP > 180/110 mmHg
- •Secondary hypertension
- •Intolerance to spironolactone
- •Permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids
- •Total cholesterol 10 mmol/l
- •New York Heart Association class III and IV
- •Pregnancy or planned pregnancy
- •Psychiatric disease
- •Malignant disease
- •Insufficient adherence
研究组 & 干预措施
addition of spironolactone
spironolactone is added to previous antihypertensive treatment
干预措施: spironolactone (Drug)
Placebo
Addition of placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change of of Systolic Blood Pressure
时间窗: 4 months
Change of systolic blood pressure from baseline to study end at four months.
Change of Diastolic Blood Pressure
时间窗: 4 months
Change of diastolic blood pressure from baseline to study end at four months.
次要结局
- Adverse Effects(4 months)
研究者
Ib Abildgaard Jacobsen
Consultant physician, associate professor
Odense University Hospital