Southern Danish Hypertension and Diabetes Study (SDHDS) With Amiloride
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- average daytime systolic and diastolic blood pressure
研究概览
简要总结
To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)
详细描述
The primary objective of this study was to evaluate the antihypertensive effect of amiloride added to triple antihypertensive treatment in patients with resistant hypertension and type 2 diabetes mellitus in an open-labelled, non- controlled and non-randomized interventional study.
The secondary objectives were to evaluate the additional effects of amiloride on:
- Urinary albumin excretion
- Blood pressure control, how many patients reached blood pressure control when amiloride was added to previous triple antihypertensive treatment.
- Plasminogen and plasmin excretion (ENaC activity) in the micro-and macroalbuminuric patients in the cohort.
- Urokinase plasminogen activator (uPA) activity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with resistant hypertension (average daytime BP >130and/or >80 mmHg by ambulatory monitoring in spite of treatment with 3 antihypertensive drugs including a diuretic and an angiotensin coverting enzyme inhibitor (AECi) or angiotensin recpetor blocker (ARBs) and a third optional, all in optimal dosages.
- •type 2 diabetes
- •prior participant in a randomized controlled trial with spironolactone, but after a wash-out periods of minimum two weeks (NCT01062763)
排除标准
- •Office blood pressure (BP) >180/110 mmHg
- •daytime average BP by ambulatory monitoring > 170/85 mmHg
- •heart failure (NYHA III-IV) Cardiac arrythmia HbA1C > 10% severe dyslipidemia known or with signs of secondary hypertension estimated glomerular filtration rate (eGFR) <50ml/min per 1.73 m2 prior intolerance to spironolactone or amiloride fertility without oral contraception pregnancy lactation
研究组 & 干预措施
Amiloride
This is a non-randomized and non-controlled study with only one treatment arm with amiloride.
干预措施: Amiloride (Drug)
结局指标
主要结局
average daytime systolic and diastolic blood pressure
时间窗: 8 weeks
ambulatory blood pressure monitoring was performed at baseline and after 8 weeks intervention with amiloride
次要结局
- plasma potassium(after 4 and 8 weeks)
- urine plasminogen and plasmin(at baseline and after 8 weeks of amiloride treatment)
- Urinary albumin excretion(after 8 weeks)
- urinary urokinase plasminogen activator (uPA) activity(At baseline and after 8 weeks of amiloride treatment)
研究者
Ib Abildgaard Jacobsen
Consultant Physician
Odense University Hospital