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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Preeclampsia Postpartum
• Intervention / Treatment: Device: Remote Patient Monitoring

Detailed Description

This study is looking at when given GDMP in post-partum women with preeclampsia, compared to the current standard of care, can this therapy improve Global Longitudinal Strain (GLS) at 9 months. Subjects who agree to participate and who have already completed the PARENT study (NCT04479072) at 6-months will be randomized in this study to either the GDMP (Treatment) arm or the standard of care (Observational) arm. Subjects that agree to participate in the extension part of the study, will add on an additional 3 months.

The primary objective of this study is to mechanistically determine the effect of GDMT administered at six months postpartum on GLS at nine months postpartum in African- American patients at high risk due to elevated blood pressures (>120/80 mmHg).

The trial biostatistician will create the randomization schedules using computer-generated random numbers and will have access to treatment group allocation. Below are further details on each arm.

Treatment Arm: Subjects randomized into the treatment arm will be enrolled into the remote patient monitoring program (RPM). Subjects who enroll in the sub-study will utilize the RPM by the University of Chicago Heart Failure Program. This program enables providers to track the number of critical vitals in real time. Patients are equipped and trained to monitor blood pressure, heart rate, weight, temperature, and medication adherence, through a Bluetooth-enabled tablet that integrates and transmits data to the clinic providers and advanced practitioners. This system is currently in use by the heart failure program at the University of Chicago, including hospital-to-home transition care after hospitalization for decompensated heart failure and long-term outpatient management of chronic heart failure, hypertension, atrial fibrillation, and ischemic heart disease. The heart failure team will provide the tablet, blood pressure cuff, weight scale and training at the subjects baseline visit.

Observational Arm: Subjects randomized to this arm will receive the standard of care based upon the American Heart Association (AHA) and American Congress of Obstetricians and Gynecologists (ACOG) guidelines, which include counseling of increased cardiovascular risk, lifestyle modifications, including a healthy diet, exercise, smoking cessation, and risk factor intervention as determined by the primary care physician. They will not be receiving the RPM program equipment.

Follow-up clinic visit approximately 3 months after they have been randomized will be scheduled in both arms. At this visit the study team will;

Perform a Transthoracic echocardiogram (TTE) Obtain Vital signs Physical Exam Adverse Event check Concomitant Medication check Blood draw for laboratory test

In addition, the study team will conduct monthly telephone interviews of all randomized trial participant's for concomitant medications, adverse events/side effects, and study drug compliance.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults between 18 and 45 years of age
2. African American
3. >120/80 BP at the time of their 6-month visit in the PARENT study
4. Diagnosed with preeclampsia
5. Initially presented to University of Chicago Medical Center (UCMC) for a Singleton Gestation Delivery
6. Completed the 6 month visit in the PARENT study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Arm; 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; 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.; Other Names: RPM
No Intervention: Observational Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Activin A levels	Comparing the difference in Activin A levels in subjects at 3 months between patients who received RPM program those in the observational group.	3 Months
Left Atrial Volume Index	Comparing the difference between left atrial volume index, from the subjects baseline to 3 month Transthoracic Echocardiogram (TTE)	3 Months
Deceleration Time	Comparing the difference between deceleration time from subjects from their baseline to 3 month TTE	3 Months
Mean Arterial Pressure	Difference in mean arterial pressure in subjects, from their baseline to 3 month TTE	3 Months
Ejection Fraction	Comparing the difference in the ejection fraction percentages, from the subjects baseline to 3 month TEE.	3 Months
Mitral Annular Motion	Comparing the difference between mitral annular motion, in millimeters (mm), from subjects baseline to 3 month TTE.	3 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Sajid H Shahul, MD PHD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Estimated): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Hypertension; Preeclampsia; Postpartum GLS Levels; Postpartum Activin A Levels; Cardiac Postpartum Therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: IRB 22-1412

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No