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| Name | Class |
|---|---|
| Idorsia Pharmaceuticals Ltd. | INDUSTRY |
| Duke University Medical Center, Durham, NC | UNKNOWN |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Month 3 in routinely collected biomarkers | 90 days | |
| Difference between exposure groups in change from baseline to Month 3 biomarker results | 90 days | |
Inclusion Criteria:
Exclusion Criteria:
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The study population will include 100 patients with inadequately controlled blood pressure despite the use of two therapies.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hypertension Center | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Incidence of edema through Month 3 for the overall cohort |
| 90 days |
| Comparative incidence of edema; for example, among users of aprocitentan versus unexposed patients | 90 days |
| Comparative incidence of hyperkalemia; for example, among users of mineralocorticoid receptor antagonists vs. unexposed patients | 90 days |
| Incidence of hospitalization due to heart failure through Month 3 for the overall cohort | 90 days |
| Comparative incidence of hospitalizations due to heart failure; for example, among users of aprocitentan versus unexposed patients | 90 days |
| Proportion discontinuing any antihypertensive medication by Month 3 for any reason for the overall cohort | 90 days |
| Comparison of antihypertensive medication discontinuation between exposure groups | 90 days |
| Proportion discontinuing any antihypertensive medication by Month 3 due to edema | 90 days |
| Comparison of antihypertensive medication discontinuation due to edema between exposure groups | 90 days |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
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