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NCT07579260
IMPACT-HTN Study of Patients With Hypertension
Conditions: Hypertension (HTN), Hypertension, Blood Pressure, High
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Vivek Bhalla
Location: Stanford University Hypertension Center Palo Alto California
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07579260). StuddyBuddy aggregates publicly available trial information.