IMPACT-HTN Study of Patients With Hypertension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVivek Bhalla
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Vivek Bhalla
Lead sponsor
Stanford University
Sponsor institution
Idorsia Pharmaceuticals Ltd.
Collaborator
Duke University Medical Center, Durham, NC
Collaborator
Source ClinicalTrials.gov