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Not yet recruitingNCT07869966Updated Oct 13, 2026

Antihypertensive Self-titration in US Primary Care

An interventional study of Self-Titration in Hypertension, sponsored by Brigham and Women's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
35 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Self-titration
  • High blood pressure
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Self-Titration

    Other: Self-Titration

Interventions

  • OtherSelf-Titration

    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.

06

What researchers measure

Primary outcomes

  1. Change in BP (blood pressure)

    Change in BP between baseline and 6 months in intervention vs. usual care

    Time frame: 180 days

Secondary outcomes

  1. Healthcare Utilization

    Outpatient visits, ED visits, hospitalizations, portal messages, phone calls

    Time frame: 180 days

  2. Side Effects and Adverse Events

    Common side effects and adverse events

    Time frame: 180 days

Other outcomes

  1. BP Knowledge

    Hypertension knowledge scale

    Time frame: 180 days

07

Study locations

1 site
  • Mass General Brigham
    Somerville, Massachusetts 02150, United States
    • Julie C Lauffenburger, PharmD, PhD · Contact
08

References and documents

Individual participant data

Plan to share: Yes — De-identified study data

Supporting information: Statistical analysis plan, Informed consent form

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869966
Responsible party
Julie Lauffenburger (Associate Professor, Brigham and Women's Hospital) — Principal investigator
First posted
Oct 13, 2026
Start date
Feb 2027 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Julie C Lauffenburger, PharmD, PhD
Contact
jlauffenburger@bwh.harvard.edu
857-282-1962

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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