Guideline-directed Management and Therapy (GDMT) for the Prevention of Postpartum Cardiac Dysfunction in Preeclamptic African American Women
NCT ID: NCT05534932
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2022-10-27
2026-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
FEMALE
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Sajid H Shahul, MD PHD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Hospital
Chicago, Illinois, United States
Countries
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Other Identifiers
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IRB 22-1412
Identifier Type: -
Identifier Source: org_study_id