HypertensionNCT07869966
Antihypertensive Self-titration in US Primary Care
A study testing Self-Titration in people with Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objective of this study is to pilot test self-titration intervention procedures. We are testing a new way to manage high blood pressure from home. In this study, patients will check their blood pressure at home and take steps to adjust their blood pressure medications if needed, following a plan outlined with a… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Self-Titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Feb 2028
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥35 years
- Prescribed 1 or 2 antihypertensives
- Average of last 3 BPs > 130/80 (home \& clinic)
- Upcoming scheduled PCP visit
- Averaged BP >130/80 at nurse visit
Who cannot join
- Unable to read English or Spanish
- Unable to self-monitor (by nurse assessment)
- Dementia or significant cognitive impairment (nurse / PCP discretion)
- Pregnant or actively seeking to become pregnant
- Terminal diagnosis or hospice
- Family member already participating in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mass General Brigham
Somerville, Massachusetts, 02150
Julie C Lauffenburger, PharmD, PhD
About this study
The objective of this study is to pilot test self-titration intervention procedures. We are testing a new way to manage high blood pressure from home. In this study, patients will check their blood pressure at home and take steps to adjust their blood pressure medications if needed, following a plan outlined with a primary care doctor. Participation in this study will last up to 6 months.
Participation will include a research visit to review the blood pressure management process. A primary care provider will also develop a medication plan for each participant to follow during the study and address any questions at their upcoming visit. During the study, each participant will be asked to check their blood pressure at home every day for 1-2 weeks a month using a study-provided blood pressure cuff. They will be asked to follow a set of instructions to request a medication change from their provider, based on their blood pressure readings. Participation may also include lab visits and additional visits with a primary care physician before making medication changes, if needed. There will also be a follow-up visit within 6 months.
- Conditions
- Hypertension
- Being tested
- Self-Titration
- Keywords
- Self-titration, High blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-TitrationOther
Following consent, patients will complete a brief baseline questionnaire, including questions about blood pressure knowledge. Staff will ensure that the patient has a validated BP cuff for home use, teach them how to use it, calibrate the cuff, and test entering values. Patients will proceed through the self-titration process for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Self-Titration | Experimental | Not described Receives: Other: Self-Titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BP (blood pressure)
Change in BP between baseline and 6 months in intervention vs. usual care
Measured: 180 days
Secondary outcomes (2)
Healthcare Utilization
Outpatient visits, ED visits, hospitalizations, portal messages, phone calls
Measured: 180 days
Side Effects and Adverse Events
Common side effects and adverse events
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startFeb 2027 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Julie Lauffenburger, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869966
- Sponsor's protocol ID
- 2026P002666
- Other IDs
- 5R34HL178960
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antihypertensive Self-titration in US Primary Care
- ClinicalTrials.gov ID
- NCT07869966
- Acronym / sponsor ID
- 2026P002666
- Conditions
- Hypertension
- Keywords
- Self-titration, High blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 13 Oct 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.
The objective of this study is to pilot test self-titration intervention procedures. We are testing a new way to manage high blood pressure from home. In this study, patients will check their blood pressure at home and take steps to adjust their blood pressure medications if needed, following a plan outlined with a primary care doctor. Participation in this study will last up to 6 months.
Participation will include a research visit to review the blood pressure management process. A primary care provider will also develop a medication plan for each participant to follow during the study and address any questions at their upcoming visit. During the study, each participant will be asked to check their blood pressure at home every day for 1-2 weeks a month using a study-provided blood pressure cuff. They will be asked to follow a set of instructions to request a medication change from their provider, based on their blood pressure readings. Participation may also include lab visits and additional visits with a primary care physician before making medication changes, if needed. There will also be a follow-up visit within 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-Titration | Experimental | Other: Self-Titration |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥35 years
- Prescribed 1 or 2 antihypertensives
- Average of last 3 BPs > 130/80 (home \& clinic)
- Upcoming scheduled PCP visit
- Averaged BP >130/80 at nurse visit
Key exclusion criteria (6 listed)
- Unable to read English or Spanish
- Unable to self-monitor (by nurse assessment)
- Dementia or significant cognitive impairment (nurse / PCP discretion)
- Pregnant or actively seeking to become pregnant
- Terminal diagnosis or hospice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-TitrationFollowing consent, patients will complete a brief baseline questionnaire, including questions about blood pressure knowledge. Staff will ensure that the patient has a validated BP cuff for home use, teach them how to use it, calibrate the cuff, and test entering values. Patients will proceed through the self-titration process for 6 months. | Other | Self-Titration |
Primary outcome
Change in BP (blood pressure)
Time frame: 180 days
Change in BP between baseline and 6 months in intervention vs. usual care
2 secondary outcomes
Healthcare Utilization
Time frame: 180 days
Side Effects and Adverse Events
Time frame: 180 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 13 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified study data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Titration in people with Hypertension, run by Brigham and Women's Hospital at 1 site 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 6 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Julie C Lauffenburger, PharmD, PhD (857-282-1962, jlauffenburger@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BP (blood pressure) (time frame: 180 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 13 Oct 2026.