Blood Pressure, High, Hypertension, Hypertension (HTN)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Vivek Bhalla
Idorsia Pharmaceuticals Ltd.
Duke University Medical Center, Durham, NC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure | 90 days |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed