Guideline-directed Management and Therapy (GDMT) for the Prevention of Postpartum Cardiac Dysfunction in Preeclamptic African American Women

NCT05534932 | Active Not Recruiting FDA Device

• 1 other identifier: IRB 22-1412
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label pilot study looking at how Guideline-directed management and therapy (GDMP) in post-partum women with preeclampsia can improve Global Longitudinal Strain (GLS).

Conditions

Preeclampsia Postpartum

Keywords

Preeclampsia; Postpartum GLS Levels; Postpartum Activin A Levels; Cardiac Postpartum Therapy; Hypertension; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• GLS percentages

  Compare GLS levels as a percentage (%) at 3 months between patients who received RPM program those in the observational group.

  3 Months

Secondary Outcomes (6)

• Difference in Activin A levels

  3 Months

• Left Atrial Volume Index

  3 Months

• Deceleration Time

  3 Months

• Mean Arterial Pressure

  3 Months

• Ejection Fraction

  3 Months

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

35 Subjects will be placed in the sub-study treatment arm. These subjects will receive the remote patient monitoring program therapy offered by the University of Chicago heart failure program.

Device: Remote Patient Monitoring

Observational Arm

NO INTERVENTION

35 Subjects will be placed in the sub-study Obervational arm. These subjects will not reveive the remote patient monitoring program and will continue with thier standard of care treatment for the duration of the study.

Interventions

Remote Patient Monitoring DEVICE

Subjects in this group will receive RPM therapy through the University of Chicago Heart Failure program. This therapy consist of a bluetooth tablet, blood pressure cuff and a health scale for subjects to bring home and take thier measurements on a daily bases up to their 3 month clinic visit. This data will then be transmitted to EPIC where the study team will retrieve the data.

Also known as: RPM

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women with diagnosed pre-eclampsia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between 18 and 45 years of age
• African American
• \>120/80 BP at the time of their 6-month visit in the PARENT study
• Diagnosed with preeclampsia
• Initially presented to University of Chicago Medical Center (UCMC) for a Singleton Gestation Delivery
• Completed the 6 month visit in the PARENT study

You may not qualify if:

• Those who cannot provide consent
• patients with preexisting cardiomyopathy, ischemic or valvular heart disease, pulmonary disease, diabetes mellitus, chronic kidney disease, multiple gestations,
• Unable to operate the RPM tablet device

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases

Study Officials

• Sajid H Shahul, MD PHD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding between arms
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized at baseline into one of two arms for the purposes of the sub-study. One arm will receive the GDMP, which includes the RPM program. The other arm will not receive the GDMP and will continue thier usual standard of care course per thier treating physician.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: October 27, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)