Prospective Early Patient Experience Initiative (IMPACT-HTN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure
研究概览
简要总结
An estimated 120 million people have high blood pressure (hypertension) in the US, of which approximately 10% have resistant hypertension. This study aims to enroll patients who continue to have hypertension while being treated with at least two medications. The study will follow patients for approximately 3 months and collect real-world information on changes in their health to identify an ideal patient profile that would benefit from 4th-line antihypertensive therapies, including, but not limited to, FDA-approved aprocitentan, renal denervation, mineralocorticoid receptor antagonists, etc.
详细描述
To date, there is little multi center data on the management of patients in HTN centers. Elevated blood pressure is the leading global risk factor for death and nonfatal cardiovascular events, primarily strokes, myocardial infarctions, heart failure leading to hospitalization, and end-stage renal disease. After a one-year pilot with two sites, this study plans to expand to additional sites to build a national registry for resistant hypertension research.
This collaborative, prospective study will evaluate the effectiveness and safety of resistant hypertension management, including the use of novel drugs with the aim of defining an ideal patient profile that would benefit from various 4th-line antihypertensive therapies, including, but not limited to, aprocitentan, renal denervation, mineralocorticoid receptor antagonists, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Signed and dated informed consent form
- •Ability to answer survey questions and to report blood pressure reading monthly
- •Male and female participants; 18 years or older
- •Treated with at least 2 antihypertensive therapies of different pharmacological classes for at least 4 weeks before the screening visit
- •Mean Sitting Systolic Blood Pressure (SiSBP) greater or equal to 130 mmHg
排除标准
- •Confirmed severe hypertension (grade 3) defined as SiSBP greater than or equal to 180 mmHg and/or Sitting Diastolic Blood Pressure (SiDBP) greater than or equal to 110 mmHg
- •Clinically significant unstable cardiac disease at screening or in the past in the opinion of the investigator
- •Heart failure NYHA functional class III and IV or NT-proBNP > 500 pg/mL
- •Severe renal insufficiency or eGFR < 15 mL/min/1.73m2
- •Moderate to severe hepatic impairment (Child-Pugh B and C) or elevated aminotransferase (> 3 x ULN)
结局指标
主要结局
Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure
时间窗: 90 days
次要结局
- Change from baseline to Month 3 in urine albumin-to-creatinine ratio (UACR) in the overall cohort and between exposure groups(90 days)
- Interaction between exposure group and baseline albuminuria category on UACR change from baseline to Month 3(90 days)
研究者
Vivek Bhalla
Associate Professor of Medicine (Nephrology)
Stanford University