A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic
研究概览
简要总结
The purpose of this study is to investigate the effect of plasma renin activity-guided therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that can be measured to determine your hypertension subtype. Once the subtype is known, doctors can prescribe specific medications to target your specific hypertension subtype. This study will investigate whether targeting the specific hypertension subtype helps to achieve blood pressure control sooner and with fewer medications compared to a standard fixed dose combination therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 150 mmHg, or diastolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 95 mmHg
- •Not currently taking BP-lowering medication
- •Clinician recommends pharmacologic treatment
- •Willing to make necessary study visits
- •Able to be contacted by phone
- •Has a primary care clinician
- •At least 18 years old
排除标准
- •Known secondary cause of hypertension
- •Pregnancy
- •Known diabetes, coronary artery disease or renal disease
- •Known sulfonamide allergy or history of gout
- •Participant's clinician recommends he/she not enroll
- •Hyponatremia, hypokalemia, hypernatremia, or hyperglycemia at baseline visit
- •Baseline visit systolic visit BP average < 140 mmHg and diastolic BP average < 90 mm Hg
- •Resting heart rate < 55 beats per minute
研究组 & 干预措施
PRA-guided therapy
Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
干预措施: Hydrochlorothiazide (Drug)
PRA-guided therapy
Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
干预措施: Lisinopril (Drug)
PRA-guided therapy
Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
干预措施: Amlodipine (Drug)
PRA-guided therapy
Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
干预措施: metoprolol (Drug)
Fixed-dose combination treatment-guided therapy
Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
干预措施: Amlodipine (Drug)
Fixed-dose combination treatment-guided therapy
Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
干预措施: metoprolol (Drug)
Fixed-dose combination treatment-guided therapy
Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
干预措施: lisinopril/hydrochlorothiazide (Drug)
结局指标
主要结局
Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic
时间窗: 4 months
At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (\<140mmHG systolic and \<90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.
次要结局
未报告次要终点
研究者
Anthony J Viera, MD, MPH
Distinguished Associate Professor
University of North Carolina, Chapel Hill