IMPACT-HTN 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, renal denervation, mineralocorticoid receptor antagonists, etc.

Conditions

Hypertension (HTN); Hypertension; Blood Pressure, High

Outcome Measures

Primary Outcomes (1)

• Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure

  90 days

Secondary Outcomes (2)

• Change from baseline to Month 3 in urine albumin-to-creatinine ratio (UACR) in the overall cohort and between exposure groups

  90 days

• Interaction between exposure group and baseline albuminuria category on UACR change from baseline to Month 3

  90 days

Other Outcomes (11)

• Change from baseline to Month 3 in routinely collected biomarkers

  90 days

• Difference between exposure groups in change from baseline to Month 3 biomarker results

  90 days

• Incidence of edema through Month 3 for the overall cohort

  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)

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: July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)