IMPACT-HTN Study of Patients With Hypertension
2026年6月24日 更新者：Vivek Bhalla
Prospective Early Patient Experience Initiative (IMPACT-HTN)
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Palo Alto、California、美国、94304
- Stanford University Hypertension Center
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接触：
- Joel Nicholus, MA
- 电话号码：650-947-7025
- 邮箱：nicholus@stanford.edu
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Hospital
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接触：
- Krista Camuglia, BSN
- 电话号码：919-862-5967
- 邮箱：krista.camuglia@duke.edu
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population will include 100 patients with inadequately controlled blood pressure despite the use of two therapies.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure
大体时间：90 days
|
90 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change from baseline to Month 3 in urine albumin-to-creatinine ratio (UACR) in the overall cohort and between exposure groups
大体时间：90 days
|
90 days
|
|
Interaction between exposure group and baseline albuminuria category on UACR change from baseline to Month 3
大体时间：90 days
|
90 days
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Change from baseline to Month 3 in routinely collected biomarkers
大体时间：90 days
|
90 days
|
|
Difference between exposure groups in change from baseline to Month 3 biomarker results
大体时间：90 days
|
90 days
|
|
Incidence of edema through Month 3 for the overall cohort
大体时间：90 days
|
90 days
|
|
Comparative incidence of edema; for example, among users of aprocitentan versus unexposed patients
大体时间：90 days
|
90 days
|
|
Comparative incidence of hyperkalemia; for example, among users of mineralocorticoid receptor antagonists vs. unexposed patients
大体时间：90 days
|
90 days
|
|
Incidence of hospitalization due to heart failure through Month 3 for the overall cohort
大体时间：90 days
|
90 days
|
|
Comparative incidence of hospitalizations due to heart failure; for example, among users of aprocitentan versus unexposed patients
大体时间：90 days
|
90 days
|
|
Proportion discontinuing any antihypertensive medication by Month 3 for any reason for the overall cohort
大体时间：90 days
|
90 days
|
|
Comparison of antihypertensive medication discontinuation between exposure groups
大体时间：90 days
|
90 days
|
|
Proportion discontinuing any antihypertensive medication by Month 3 due to edema
大体时间：90 days
|
90 days
|
|
Comparison of antihypertensive medication discontinuation due to edema between exposure groups
大体时间：90 days
|
90 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年4月1日
研究完成 (估计的)
2027年4月1日
研究注册日期
首次提交
2026年5月6日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年6月29日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.