Managing heart health in postpartum African American women with preeclampsia
Guideline-directed Management and Therapy (GDMT) for the Prevention of Postpartum Cardiac Dysfunction in Preeclamptic African American Women
This study is testing if a special heart health program can help African American women who had preeclampsia feel better after giving birth compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05534932 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of Guideline-directed management and therapy (GDMT) on postpartum cardiac health in African American women who have experienced preeclampsia. Participants, who have completed a prior study, will be randomized to receive either GDMT or standard care, with the aim of improving Global Longitudinal Strain (GLS) at nine months postpartum. The study includes a remote patient monitoring program to track vital signs and medication adherence. The primary goal is to assess the impact of GDMT on cardiac function in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are African American women aged 18 to 45 who have been diagnosed with preeclampsia and have elevated blood pressure at their six-month postpartum visit.
Not a fit: Patients with preexisting heart conditions or those unable to operate the remote monitoring device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiac health outcomes for postpartum women with a history of preeclampsia.
How similar studies have performed: While this approach is novel in its specific focus on postpartum African American women with preeclampsia, similar studies have shown promise in managing cardiac health through remote monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- University of Chicago Hospital — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Sajid H Shahul, MD PHD — University of Chicago
- Study coordinator: Sajid Shahul, MD phd
- Email: sshahul1@dacc.uchicago.edu
- Phone: 773-398-2956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.