A Prospective Registry Study of Patients With Hypertension

Prospective Early Patient Experience Initiative (IMPACT-HTN)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Blood Pressure, High; Hypertension (HTN)

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.

This collaborative, prospective study will evaluate the effectiveness and safety of hypertension management, including the use of novel drugs such as aprocitentan in real-world practice, with the aim of defining an ideal patient profile that would benefit from various 4th-line antihypertensive therapies, including, but not limited to, aprocitentan.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Hypertension Center
      • Contact: Joel Nicholus, MA; Phone Number: 650-947-7025; Email: nicholus@stanford.edu
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
      • Contact: Krista Camuglia, BSN; Phone Number: 919-862-5967; Email: krista.camuglia@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include 100 patients with inadequately controlled blood pressure despite the use of two therapies.

Description

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)
• Known allergic reaction to Aprocitentan
• Concomitant use of other endothelin receptor antagonists

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to Month 3 in mean sitting office SBP	90 days
Change from baseline to Month 3 in albuminuria, in the overall population and in patients with micro and macroalbuminuria at baseline.	90 days
Incidence of edema during the duration of the study.	90 days
Laboratory abnormalities and hospitalizations for heart failure. Hospitalization due to heart failure during the duration of the study	90 days
Discontinuations due to edema during the duration of the study	90 days

Collaborators and Investigators

• Sponsor: Vivek Bhalla
• Collaborators: Idorsia Pharmaceuticals Ltd.; Duke University Medical Center, Durham, NC

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 86433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No