Effect of Statin Use on Aldosterone Secretion
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Serum aldosterone following angiotensin II infusion
研究概览
简要总结
The purpose of this research protocol is to determine if the same effects are observed in vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the widely used statin class of medications on the mineralocorticoid pathway would likely have significant clinical implications on the future management of hypertension and other cardiovascular disease given the known pleiotropy of aldosterone action.
详细描述
In order to provide additional evidence regarding the effect of statin therapy on aldosterone levels, the investigators propose the following randomized, double-blinded, placebo controlled protocol in relatively healthy volunteers. The investigators will evaluate aldosterone and cortisol production in response to an angiotensin II infusion under the following test conditions: 1) placebo, 2) simvastatin therapy (lipophilic statin), and 3) pravastatin therapy (hydrophilic statin). Measurements will be made to assess the effect of both acute (single dose) and chronic (6 and 12 weeks) therapy of the two statin medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Blood pressure <140/90 mmHg and >90/50 mmHg
- •Body mass index 19-40 kg/m2
- •Normal screening laboratory values for:
- •i. Serum sodium, potassium, glucose, liver enzymes ii. GFR (>60 mL/min/1.73m2) iii. A1c iv. TSH
- •Normal ECG
- •Negative urine HCG at screening for women who are able to become pregnant.
排除标准
- •Any prior use of statin therapy
- •History of coronary disease, diabetes, hypertension, stroke, kidney disease, thyroid disease, psychiatric illness, malignancy, preeclampsia, or illness requiring overnight hospitalization in the past 6 months
- •Triglycerides > 500, LDL > 200
- •Any prescription medication or herbal medication including oral contraceptive, excluding thyroid medications
- •Unstable thyroid disease (determined by abnormal TSH)
- •Pregnancy or current breastfeeding
- •Alcohol intake >12 oz per week
- •Tobacco or recreational drug use
研究组 & 干预措施
Placebo
Placebo prepared by Investigational Drug Services at Brigham and Women's Hospital
干预措施: Placebo (Other)
Simvastatin
Subjects in the simvastatin arm will receive simvastatin 20 mg daily for 6 weeks before having their lipids checked. If their LDL-c decreases by less than 35% from screening, then the dose of simvastatin is increased to 40 mg daily for the following 6 weeks.
干预措施: Simvastatin (Drug)
Pravastatin
Subjects in the pravastatin arm will receive pravastatin 40 mg daily for 6 weeks before having their lipids checked. If their LDL-c decreases by less than 35% from screening, then the dose of pravastatin is increased to 80 mg daily for the following 6 weeks.
干预措施: Pravastatin (Drug)
结局指标
主要结局
Serum aldosterone following angiotensin II infusion
时间窗: 3 months
次要结局
- 24 hour urine aldosterone(3 months)
研究者
Jonathan S. Williams, MD, MMSc
Associate Physician
Brigham and Women's Hospital