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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will include 100 patients with inadequately controlled blood pressure despite the use of two therapies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure
Time frame
90 daysSecondary outcomes
1
Change from baseline to Month 3 in urine albumin-to-creatinine ratio (UACR) in the overall cohort and between exposure groups
Time frame
90 days2
Interaction between exposure group and baseline albuminuria category on UACR change from baseline to Month 3
Time frame
90 daysOther outcomes
1
Change from baseline to Month 3 in routinely collected biomarkers
Time frame
90 days2
Difference between exposure groups in change from baseline to Month 3 biomarker results
Time frame
90 days3
Incidence of edema through Month 3 for the overall cohort
Time frame
90 days4
Comparative incidence of edema; for example, among users of aprocitentan versus unexposed patients
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vivek Bhalla
Lead sponsor
Stanford University
Sponsor institution
Idorsia Pharmaceuticals Ltd.
Collaborator
Duke University Medical Center, Durham, NC
Collaborator
Source ClinicalTrials.gov
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