Hypertensive Disorders of Pregnancy (HDP)HEART at HomeNCT07833904
Postpartum Home Visiting (HEART at Home)
An observational study of Hypertensive Disorders of Pregnancy (HDP), run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether HEART at Home (Home-based Engagement And Remote Treatment for Hypertension), a home-based postpartum hypertension care program, is feasible and acceptable for people with high blood pressure after delivery and the health care teams caring for them. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertensive Disorders of Pregnancy (HDP)
- What is being tested?
- HEART at Home
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 15 Oct 2026
- How long will I take part?
- 3 Months
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of HDP-including chronic hypertension, gestational hypertension, preeclampsia, eclampsia, HELLP syndrome, or chronic hypertension with superimposed preeclampsia- enrolled at time of delivery.
Who may be able to join
- • Age ≥18 years
- Enrollment in the Barnes Jewish Hospital rBPM program; as per eligibility criteria above, patient has a physician-made diagnosis of HDP per American College of Obstetricians and gynecologists criteria
- Measured at least 4 days of blood pressure during initial program
- At least one blood pressure was made after monitoring day 7
- Confirmed at least two separate blood pressure ≥130/80 mm Hg at the end of the 14-day rBPM period
- Ability and willingness to participate in home visits and remote monitoring
- Able to communicate in English or Spanish without the need for interpretation services
Who cannot join
- • Inability to provide informed consent
- Physician determination of inability to measure blood pressure at home due to comorbidities or other limiting conditions
- No access to a phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HEART at Home: Improving Postpartum Cardiovascular Outcomes Through Implementation of a Hybrid Home-Based and Remote Blood Pressure Management Model for Hypertensive Disorders of Pregnancy
The goal of this clinical trial is to learn whether HEART at Home (Home-based Engagement And Remote Treatment for Hypertension), a home-based postpartum hypertension care program, is feasible and acceptable for people with high blood pressure after delivery and the health care teams caring for them. The main questions it aims to answer are:
Is HEART at Home feasible to deliver, including successful enrollment, completion of home visits and blood pressure monitoring, and delivery of the planned intervention? Is HEART at Home acceptable to participants and health care providers?
Read more
The study will also explore changes in blood pressure control and track emergency room visits and hospital readmissions related to high blood pressure.
Participants will:
Measure their blood pressure at home using a provided blood pressure cuff and securely share their readings with the health care team.
Receive home visits and phone or text check-ins from trained postpartum doulas for the first three months after delivery. Doulas will provide education, assist with blood pressure monitoring, and help participants connect with ongoing medical care.
Have their blood pressure readings reviewed by nurses and doctors, who may adjust blood pressure medications as needed.
At 12 weeks after delivery, a plan set for ongoing care with a primary care provider or heart specialist.
Read the detailed description
High blood pressure during and after pregnancy can put people at risk for serious health problems after delivery. Many patients do not receive enough follow-up care once they leave the hospital, and high blood pressure can continue or worsen in the weeks after childbirth.
This study will test whether a new care approach is practical and acceptable for patients and health care teams. The study combines home blood pressure monitoring, home visits by trained postpartum doulas, and telehealth visits with medical providers during the first three months after delivery. This novel intervention is called HEART at Home (Home-based Engagement And Remote Treatment for Hypertension).
People who recently gave birth and have ongoing high blood pressure will be invited to join the study. Participants will measure their blood pressure at home using a provided cuff and share their readings through a secure mobile system. Nurses and doctors will review these readings and adjust blood pressure medications when needed. Participants will also receive home visits and phone or text check-ins from trained postpartum doulas, who will provide education, help with blood pressure measurement, and support in connecting to ongoing medical care. At about 12 weeks after delivery, participants will have planning for future care with a primary care provider or heart specialist.
The study will collect information about how easy the program is to carry out, how often participants complete visits, and how helpful participants and providers find the program. The study will also track blood pressure control and any emergency room visits or hospital readmissions related to blood pressure. This information will be used to improve postpartum care for people with high blood pressure in the future.
- Being tested
- HEART at Home
- Keywords
- postpartum hypertension, community-based care strategies, remote blood pressure monitoring, home visiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEART at HomeBehavioural
The intervention integrates biweekly home visitor-led BP monitoring and health education, extended rBPM through 12 weeks, protocol-driven escalation to the clinical team, and clinician-supervised medication management and telehealth follow-up. Core components of HEART at Home include: 1) home visiting-based BP measurement and support for patient-initiated rBPM between visits, 2) cardiovascular risk assessment and patient education, 3) protocolized clinical escalation and pharmacologic management, and 4) facilitated linkage to longitudinal clinical care.
| Study group | Role | What they receive |
|---|---|---|
| HEART at Home Cohort | This study includes a single study population: postpartum individuals aged 18 years or older with a diagnosis of a hypertensive disorder of pregnancy who have persistent elevated blood pressure following delivery. There is no control group. All participants are enrolled prospectively. No participants are enrolled under a waiver of consent.Participants will be enrolled at the conclusion of the standard 14-day postpartum rBPM program and followed from weeks 3 through 12 postpartum. Participants will receive three in-person home visits conducted by trained PAT home visitors at approximately 4, 8, and 12 weeks postpartum, consistent with the standard PAT service delivery model. Receives: Behavioral: HEART at Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption
Completion of >=1 home visit with blood pressure measurement and transmission to clinical team
Measured: continuous across 12 weeks
Reduction in Systolic BP
Reduction in Systolic BP
Measured: 6 and 12 weeks postpartum
Secondary outcomes (6)
Reduction in Diastolic Blood Pressure
Reduction in Diastolic Blood Pressure
Measured: 6 weeks and 12 weeks postpartum
Number of Blood-Pressure Lowering Medication Changes
Any initiation, discontinuation, dose change, or change in antihypertensive medication during weeks 2-12 postpartum.
Measured: Continuous, 2-12 weeks postpartum
Blood pressure Control
Proportion of patients with BP <130/80 mm Hg
Measured: 6 and 12 weeks postpartum
Fidelity
Completion of three scheduled in-person home visits, participation in remote BP monitoring during the intervention period with appropriate escalation of abnormal BP or symptoms
Measured: continuous, 2-12 weeks postpartum
Reach
Recruitment rate over study enrollment period
Measured: Baseline (3-5 days postpartum)
Time-Based Cost
number of additional minutes needed to deliver HEART at Home components at each home visit
Measured: continuous, 2-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Jul 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Disorders of Pregnancy (HDP)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Parents as Teachers
- Responsible party
- Sponsor
- Investigators
- Aishwarya Vijay, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833904
- Sponsor's protocol ID
- 202601109
- Other IDs
- T32HL007081
- Acronym
- HEART at Home
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared because this is a small pilot study involving sensitive health information, and the small sample size may increase the risk of participant re-identification. Aggregate study results will be reported through ClinicalTrials.gov and scientific publications and presentations, as applicable.
Publications
Vijay A, Oh I, Lewis A, Sabol BA, Frolova AI, Huffman MD, Mahmoud Z, Rampersad R. Postpartum blood pressure monitoring across hypertensive disorders of pregnancy. Pregnancy Hypertens. 2026 Sep 8;46:101520. doi: 10.1016/j.preghy.2026.101520. Online ahead of print.
PubMed 42710173
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEART at Home: Improving Postpartum Cardiovascular Outcomes Through Implementation of a Hybrid Home-Based and Remote Blood Pressure Management Model for Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT07833904
- Acronym / sponsor ID
- HEART at Home / 202601109
- Keywords
- postpartum hypertension, community-based care strategies, remote blood pressure monitoring, home visiting
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Parents as Teachers
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 22 Sep 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 goal of this clinical trial is to learn whether HEART at Home (Home-based Engagement And Remote Treatment for Hypertension), a home-based postpartum hypertension care program, is feasible and acceptable for people with high blood pressure after delivery and the health care teams caring for them. The main questions it aims to answer are:
Is HEART at Home feasible to deliver, including successful enrollment, completion of home visits and blood pressure monitoring, and delivery of the planned intervention? Is HEART at Home acceptable to participants and health care providers?
The study will also explore changes in blood pressure control and track emergency room visits and hospital readmissions related to high blood pressure.
Participants will:
Measure their blood pressure at home using a provided blood pressure cuff and securely share their readings with the health care team.
Receive home visits and phone or text check-ins from trained postpartum doulas for the first three months after delivery. Doulas will provide education, assist with blood pressure monitoring, and help participants connect with ongoing medical care.
Have their blood pressure readings reviewed by nurses and doctors, who may adjust blood pressure medications as needed.
At 12 weeks after delivery, a plan set for ongoing care with a primary care provider or heart specialist.
Detailed description
High blood pressure during and after pregnancy can put people at risk for serious health problems after delivery. Many patients do not receive enough follow-up care once they leave the hospital, and high blood pressure can continue or worsen in the weeks after childbirth.
This study will test whether a new care approach is practical and acceptable for patients and health care teams. The study combines home blood pressure monitoring, home visits by trained postpartum doulas, and telehealth visits with medical providers during the first three months after delivery. This novel intervention is called HEART at Home (Home-based Engagement And Remote Treatment for Hypertension).
People who recently gave birth and have ongoing high blood pressure will be invited to join the study. Participants will measure their blood pressure at home using a provided cuff and share their readings through a secure mobile system. Nurses and doctors will review these readings and adjust blood pressure medications when needed. Participants will also receive home visits and phone or text check-ins from trained postpartum doulas, who will provide education, help with blood pressure measurement, and support in connecting to ongoing medical care. At about 12 weeks after delivery, participants will have planning for future care with a primary care provider or heart specialist.
The study will collect information about how easy the program is to carry out, how often participants complete visits, and how helpful participants and providers find the program. The study will also track blood pressure control and any emergency room visits or hospital readmissions related to blood pressure. This information will be used to improve postpartum care for people with high blood pressure in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEART at Home Cohort | – | Behavioral: HEART at HomeThis study includes a single study population: postpartum individuals aged 18 years or older with a diagnosis of a hypertensive disorder of pregnancy who have persistent elevated blood pressure following delivery. There is no control group. All participants are enrolled prospectively. No participants are enrolled under a waiver of consent.Participants will be enrolled at the conclusion of the standard 14-day postpartum rBPM program and followed from weeks 3 through 12 postpartum. Participants will receive three in-person home visits conducted by trained PAT home visitors at approximately 4, 8, and 12 weeks postpartum, consistent with the standard PAT service delivery model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of HDP-including chronic hypertension, gestational hypertension, preeclampsia, eclampsia, HELLP syndrome, or chronic hypertension with superimposed preeclampsia- enrolled at time of delivery.
Key inclusion criteria (7 listed)
- • Age ≥18 years
Key exclusion criteria (3 listed)
- • Inability to provide informed consent
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 |
|---|---|---|
| HEART at HomeThe intervention integrates biweekly home visitor-led BP monitoring and health education, extended rBPM through 12 weeks, protocol-driven escalation to the clinical team, and clinician-supervised medication management and telehealth follow-up. Core components of HEART at Home include: 1) home visiting-based BP measurement and support for patient-initiated rBPM between visits, 2) cardiovascular risk assessment and patient education, 3) protocolized clinical escalation and pharmacologic management, and 4) facilitated linkage to longitudinal clinical care. | Behavioural | HEART at Home Cohort |
Primary outcome
Adoption
Time frame: continuous across 12 weeks
Completion of >=1 home visit with blood pressure measurement and transmission to clinical team
Reduction in Systolic BP
Time frame: 6 and 12 weeks postpartum
Reduction in Systolic BP
6 secondary outcomes
Reduction in Diastolic Blood Pressure
Time frame: 6 weeks and 12 weeks postpartum
Number of Blood-Pressure Lowering Medication Changes
Time frame: Continuous, 2-12 weeks postpartum
Blood pressure Control
Time frame: 6 and 12 weeks postpartum
Fidelity
Time frame: continuous, 2-12 weeks postpartum
Reach
Time frame: Baseline (3-5 days postpartum)
Time-Based Cost
Time frame: continuous, 2-12 weeks
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 22 Sep 2026.
- Background: PubMed 42710173Vijay A, Oh I, Lewis A, Sabol BA, Frolova AI, Huffman MD, Mahmoud Z, Rampersad R. Postpartum blood pressure monitoring across hypertensive disorders of pregnancy. Pregnancy Hypertens. 2026 Sep 8;46:101520. doi: 10.1016/j.preghy.2026.101520. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are not planned to be shared because this is a small pilot study involving sensitive health information, and the small sample size may increase the risk of participant re-identification. Aggregate study results will be reported through ClinicalTrials.gov and scientific publications and presentations, as applicable.
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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. This study is not recruiting at the moment.
Aishwarya Vijay, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Disorders of Pregnancy (HDP), run by Washington University School of Medicine 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption (time frame: continuous across 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07833904, which also lists 1 linked publication.
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 22 Sep 2026.