Hypertension in PregnancymHEARTNCT06523569
Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
A study testing Digital Blood Pressure Monitoring System and Mobile health application in people with Hypertension in Pregnancy and Pre-Eclampsia, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Hypertension in Pregnancy, Pre-Eclampsia, Eclampsia
- What is being tested?
- Digital Blood Pressure Monitoring System and Mobile health application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2024to 1 Dec 2026
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Delivery at Northwestern Memorial Hospital (Prentice Women's Hospital)
- Live birth at any gestational age
- Pregnancy complicated by new-onset HDP (pre-eclampsia, eclampsia, or gestational hypertension)
Who cannot join
- HELLP syndrome
- History of chronic diseases pre-pregnancy (hypertension, diabetes, cardiovascular disease, chronic renal disease)
- Current Omron remote patient monitoring or Noom user
- BMI<18.5 kg/m2 at enrollment
- Inadequate gestational weight gain or gestational weight loss
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Dept. of Cardiology
Chicago, Illinois, 60611
About this study
The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).
Read the detailed description
The purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (HDP). All participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. If randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a digital blood pressure monitoring system, and asked to utilize these at home during the one year of the study along with usual care. If randomized to the control arm, the participant will receive care as usual.
- Being tested
- Digital Blood Pressure Monitoring System, Mobile health application
- Keywords
- digital health, echocardiogram, blood pressure
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Blood Pressure Monitoring SystemOther
As a part of the bundled digital health intervention, the participant will receive instructions on how to follow a link in their electronic patient portal that will allow direct input of home blood pressure readings for clinical review.
Mobile health applicationOther
As a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Control) | No intervention | Participant will receive usual care. |
| Bundled digital health intervention | Experimental | Participant will be enrolled in a digital blood pressure monitoring program and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care. Receives: Other: Digital Blood Pressure Monitoring System; Other: Mobile health application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
All participants will have systolic blood pressure measured at 3 months and 12 months postpartum
Measured: 3 months postpartum; 12 months postpartum
Secondary outcomes (5)
Weight
All participants will have weight measured at 3 months and 12 months postpartum
Measured: 3 months postpartum; 12 months postpartum
Subclinical cardiovascular dysfunction via echocardiography
All participants will have echocardiography performed at 3 months and 12 months postpartum to assess subclinical cardiovascular dysfunction
Measured: 3 months postpartum; 12 months postpartum
Study feasibility
The investigators will assess study feasibility (% enrolled in digital health intervention) at the end of the study
Measured: 12 months postpartum
Participant engagement
The investigators will assess participant engagement (% continuing to actively use digital health interventions) at the end of the study
Measured: 12 months postpartum
Anti-hypertensive medication use (%)
The investigators will assess participant anti-hypertensive medication use (%) at 3 months and 12 months
Measured: 3 months postpartum; 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start7 Nov 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Friends of Prentice, Senior Faculty Academy
- Responsible party
- Principal investigator, Priya Freaney, Northwestern University
- Investigators
- Priya M Freaney, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523569
- Sponsor's protocol ID
- STU00219095
- Acronym
- mHEART
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2024
- Last updated
- 8 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT06523569
- Acronym / sponsor ID
- mHEART / STU00219095
- Keywords
- digital health, echocardiogram, blood pressure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Friends of Prentice, Senior Faculty Academy
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Jul 2024 (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 purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).
Detailed description
The purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (HDP). All participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. If randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a digital blood pressure monitoring system, and asked to utilize these at home during the one year of the study along with usual care. If randomized to the control arm, the participant will receive care as usual.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Control) | No intervention | –Participant will receive usual care. |
| Bundled digital health intervention | Experimental | Other: Digital Blood Pressure Monitoring System, Other: Mobile health applicationParticipant will be enrolled in a digital blood pressure monitoring program and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Delivery at Northwestern Memorial Hospital (Prentice Women's Hospital)
- Live birth at any gestational age
- Pregnancy complicated by new-onset HDP (pre-eclampsia, eclampsia, or gestational hypertension)
Key exclusion criteria (5 listed)
- HELLP syndrome
- History of chronic diseases pre-pregnancy (hypertension, diabetes, cardiovascular disease, chronic renal disease)
- Current Omron remote patient monitoring or Noom user
- BMI<18.5 kg/m2 at enrollment
- Inadequate gestational weight gain or gestational weight loss
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 |
|---|---|---|
| Digital Blood Pressure Monitoring SystemAs a part of the bundled digital health intervention, the participant will receive instructions on how to follow a link in their electronic patient portal that will allow direct input of home blood pressure readings for clinical review. | Other | Bundled digital health intervention |
| Mobile health applicationAs a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application. | Other | Bundled digital health intervention |
Primary outcome
Systolic blood pressure
Time frame: 3 months postpartum; 12 months postpartum
All participants will have systolic blood pressure measured at 3 months and 12 months postpartum
5 secondary outcomes
Weight
Time frame: 3 months postpartum; 12 months postpartum
Subclinical cardiovascular dysfunction via echocardiography
Time frame: 3 months postpartum; 12 months postpartum
Study feasibility
Time frame: 12 months postpartum
Participant engagement
Time frame: 12 months postpartum
Anti-hypertensive medication use (%)
Time frame: 3 months postpartum; 12 months postpartum
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 8 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. This study is not recruiting at the moment.
Priya M Freaney, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Blood Pressure Monitoring System and Mobile health application in people with Hypertension in Pregnancy and Pre-Eclampsia, run by Northwestern University 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 3 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: under way, not looking for participants, as of the sponsor's last update on 8 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 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?
Systolic blood pressure (time frame: 3 months postpartum; 12 months postpartum). 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 8 Jun 2026.