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NCT Number: NCT07579260

IMPACT-HTN Study of Patients With Hypertension

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University Hypertension Center, Palo Alto, California, United States

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About this study

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. After a one-year pilot with two sites, this study plans to expand to additional sites to build a national registry for resistant hypertension research.

This collaborative, prospective study will evaluate the effectiveness and safety of resistant hypertension management, including the use of novel drugs with the aim of defining an ideal patient profile that would benefit from various 4th-line antihypertensive therapies, including, but not limited to, aprocitentan, renal denervation, mineralocorticoid receptor antagonists, etc.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: 90 days

Secondary 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 days

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

    Time frame: 90 days

Other outcomes

  1. Change from baseline to Month 3 in routinely collected biomarkers

    Time frame: 90 days

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

    Time frame: 90 days

  3. Incidence of edema through Month 3 for the overall cohort

    Time frame: 90 days

  4. Comparative incidence of edema; for example, among users of aprocitentan versus unexposed patients

    Time frame: 90 days

  5. Comparative incidence of hyperkalemia; for example, among users of mineralocorticoid receptor antagonists vs. unexposed patients

    Time frame: 90 days

  6. Incidence of hospitalization due to heart failure through Month 3 for the overall cohort

    Time frame: 90 days

  7. Comparative incidence of hospitalizations due to heart failure; for example, among users of aprocitentan versus unexposed patients

    Time frame: 90 days

  8. Proportion discontinuing any antihypertensive medication by Month 3 for any reason for the overall cohort

    Time frame: 90 days

  9. Comparison of antihypertensive medication discontinuation between exposure groups

    Time frame: 90 days

  10. Proportion discontinuing any antihypertensive medication by Month 3 due to edema

    Time frame: 90 days

  11. Comparison of antihypertensive medication discontinuation due to edema between exposure groups

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Vivek Bhalla

Other

Collaborators

  • Duke University Medical Center, Durham, NC
  • Idorsia Pharmaceuticals Ltd.

Registry information

Official study title

Prospective Early Patient Experience Initiative (IMPACT-HTN)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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