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NCT Number: NCT06523569

Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Eclampsia Female Urogenital Diseases and Pregnancy Complications Gestational Hypertension Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Dept. of Cardiology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Digital Blood Pressure Monitoring System

Other

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 application

Other

As a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application.

Primary outcomes

  1. 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

Secondary outcomes

  1. Weight

    Time frame: 3 months postpartum; 12 months postpartum

    All participants will have weight measured at 3 months and 12 months postpartum

  2. Subclinical cardiovascular dysfunction via echocardiography

    Time frame: 3 months postpartum; 12 months postpartum

    All participants will have echocardiography performed at 3 months and 12 months postpartum to assess subclinical cardiovascular dysfunction

  3. Study feasibility

    Time frame: 12 months postpartum

    The investigators will assess study feasibility (% enrolled in digital health intervention) at the end of the study

  4. Participant engagement

    Time frame: 12 months postpartum

    The investigators will assess participant engagement (% continuing to actively use digital health interventions) at the end of the study

  5. Anti-hypertensive medication use (%)

    Time frame: 3 months postpartum; 12 months postpartum

    The investigators will assess participant anti-hypertensive medication use (%) at 3 months and 12 months

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Friends of Prentice
  • Senior Faculty Academy

Registry information

Acronym: mHEART

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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