Investigation of Reduction of Blood Pressure and Metabolic Rate in Obese Hypertensive Patients Using Eplerenone: Implications for Treatment of Hypertension and Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Basal metabolic rate
研究概览
简要总结
Obesity and hypertension are independent risks for congestive heart failure (CHF) and chronic kidney disease. In obesity induced hypertension, the most common cause of human essential hypertension, the potential importance of mineralocorticoid receptor blockade has not been widely investigated. We propose to test the hypothesis that eplerenone reduces metabolic demand, improves cardiac function and attenuates glomerular hyperfiltration and microalbuminuria in obese patients. Our specific aims are to assess changes in basal metabolic rate, cardiac and renal function in obese hypertensive subjects treated with eplerenone compared to amlodipine.
详细描述
The proposed trial will utilize an open label study design. Patients with hypertension and obesity will be recruited. After a 3-week washout period for patients currently on antihypertensive medication, eligible participants will be assigned to receive 25 mg of eplerenone or 5 mg of amlodipine. After a 4 week period on medication, drug will be advanced to 50 mg of eplerenone or 10 mg of amlodipine for an additional 4 weeks.
Protocol Synopsis:
- Recruit 20 study participants with a systolic blood pressure (SBP) between 140 and 160 mmHg and/or a diastolic blood pressure between 90 and 100 mmHg who also have a body mass index > 30-45. If participants are on antihypertensive treatment, they will undergo a 3-week washout period. The study participants will be identified in the Division of Hypertension.
- Assign study participants to receive 25 mg of eplerenone or 5 mg of amlodipine per day for 4 weeks. Up-titration to eplerenone 50 mg and amlodipine 10 mg for an additional 4 weeks.
- Obtain basal metabolic rate, cardiac output and other indices of cardiac performance, cognitive abilities, and rating of depression and anxiety symptoms at baseline and after 8 weeks of treatment.
- Obtain blood pressure measures at all visits.
- Obtain mood ratings at all visits.
- Compare basal metabolic rate, cardiac output and other indices of cardiac performance between treatment groups.
- Compare difference in SBP and DBP between treatment groups.
- Compare differences in plasma insulin, serum electrolytes, plasma renin activity, cortisol and aldosterone concentrations, urinary albumin excretion, and glomerular filtration rate between treatment groups.
- Compare mood rating as well as symptoms of depression and anxiety between treatment groups.
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
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure (SBP) between 140 and 160 mmHg and/or a diastolic blood pressure between 90 and 100 mmHg who also have a body mass index > 30-
- •Women must be post menopausal
排除标准
- •Women of child bearing potential
- •BMI less than 30 or greater than 45
- •A creatinine > 1.8 for females and > 2.0 for males
- •Type 1 or type 2 diabetes
- •Current evidence of alcohol or drug abuse problems
研究组 & 干预措施
eplerenone
干预措施: eplerenone, amlodipine (Drug)
eplerenone
干预措施: eplerenone (Drug)
eplerenone
干预措施: amlodipine (Drug)
amlodipine
Amlodipine 5-10mg daily times 8 weeks
干预措施: eplerenone, amlodipine (Drug)
amlodipine
Amlodipine 5-10mg daily times 8 weeks
干预措施: eplerenone (Drug)
amlodipine
Amlodipine 5-10mg daily times 8 weeks
干预措施: amlodipine (Drug)
结局指标
主要结局
Basal metabolic rate
时间窗: Pre and post treatment
次要结局
未报告次要终点
研究者
Marion Wofford
Professor
University of Mississippi Medical Center