Hypertension (HTN)NCT07579260
IMPACT-HTN Study of Patients With Hypertension
An observational study of Hypertension (HTN) and Hypertension, run by Vivek Bhalla at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN), Hypertension, Blood Pressure, High
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2026to 1 Apr 2027
- How long will I take part?
- 97 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include 100 patients with inadequately controlled blood pressure despite the use of two therapies.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Duke University Hospital
Durham, North Carolina, 27710
Krista Camuglia, BSN, 919-862-5967, krista.camuglia@duke.edu
Stanford University Hypertension Center
Palo Alto, California, 94304
Joel Nicholus, MA, 650-947-7025, nicholus@stanford.edu
About this study
Official title: 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, renal denervation, mineralocorticoid receptor antagonists, etc.
Read the 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. 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.
- Conditions
- Hypertension (HTN), Hypertension, Blood Pressure, High
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure
Measured: 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
Measured: 90 days
Interaction between exposure group and baseline albuminuria category on UACR change from baseline to Month 3
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 97 Days
Sponsor and investigators
- Lead sponsor
- Vivek Bhalla
- Sponsor type
- University, hospital or other
- Collaborators
- Idorsia Pharmaceuticals Ltd., Duke University Medical Center, Durham, NC
- Responsible party
- Sponsor-investigator, Vivek Bhalla, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579260
- Sponsor's protocol ID
- 86433
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Early Patient Experience Initiative (IMPACT-HTN)
- ClinicalTrials.gov ID
- NCT07579260
- Acronym / sponsor ID
- 86433
- Conditions
- Hypertension (HTN), Hypertension, Blood Pressure, High
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vivek BhallaUniversity, hospital or other
- Collaborators
- Idorsia Pharmaceuticals Ltd., Duke University Medical Center, Durham, NC
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 97 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 100 patients with inadequately controlled blood pressure despite the use of two therapies.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure
Time frame: 90 days
2 secondary outcomes
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
Interaction between exposure group and baseline albuminuria category on UACR change from baseline to Month 3
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension (HTN) and Hypertension, run by Vivek Bhalla at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.