A Prospective Registry Study of Patients With Hypertension

NCT07579260 | Not Yet Recruiting

• 1 other identifier: 86433
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension (HTN); Hypertension; Blood Pressure, High

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivek Bhalla: lead
• Idorsia Pharmaceuticals Ltd.: collaborator
• Duke University Medical Center, Durham, NC: collaborator

Study Sites (2)

Stanford University Hypertension Center

Palo Alto, California, 94304, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 97 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine (Nephrology)

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)