Assessing cardiovascular health after preeclampsia
Identification of Early HFpEF After Preeclampsia by Exercise Stress Testing
Vanderbilt University Medical Center · NCT06741436
This study looks at the heart health of women who had preeclampsia during pregnancy to see if it affects their cardiovascular risks later on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06741436 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the cardiovascular health of women who have experienced preeclampsia during pregnancy. Participants will be identified through electronic health records and will include both women diagnosed with preeclampsia and a control group without the condition. The study will focus on understanding the long-term cardiovascular risks associated with preeclampsia, particularly in relation to endothelial dysfunction and heart health. Recruitment will occur during the third trimester and at the time of labor and delivery, with a target enrollment of 250 cases and 250 controls.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old who have given birth at Vanderbilt University Medical Center and have been diagnosed with preeclampsia.
Not a fit: Patients who are under 18, unable to provide informed consent, or have significant pre-existing cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular risks in women post-preeclampsia.
How similar studies have performed: While studies on cardiovascular health post-preeclampsia are emerging, this specific approach focusing on endothelial dysfunction and long-term outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women age \> 18 years 2. Give birth at VUMC 3. Have a diagnosis of PreE based on accepted American College of Obstetricians and Gynecologists criteria Exclusion Criteria: 1. Age \<18 years old 2. Unable to provide informed consent 3. Does not speak English 4. Active COVID-19 infection 5. Residual symptoms related to prior COVID-19 infection 6. HIV infection 7. Hepatitis B or C infection 8. Pulmonary arterial hypertension 9. Sickle cell disease 10. Pulmonary embolism 11. Pre-existing cardiomyopathy 12. Coronary artery disease 13. Active substance abuse (other than tobacco or marijuana) 14. Unable to attend postpartum visits Controls 1\. Enrolling controls who meet the same inclusion/exclusion criteria, except they do not have preeclampsia and do not have pre-existing diabetes or chronic hypertension.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Kathryn Lindley, MD, FACC — VUMC
- Study coordinator: Olivia H Patridge, BS
- Email: olivia.h.patridge@vumc.org
- Phone: 615-875-2942
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.
Conditions: Preeclampsia, Heart Failure Preserved Ejection Fraction, Hypertension, CPET, Placental vascular dysfunction, echo