| NCT ID | NCT06741436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Preeclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-02-18 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Though cardiovascular disease (CVD) is the leading cause of mortality in women, traditional epidemiology in this area has focused on later life, when cardiometabolic risk has already exacted a cumulative toll on the vascular system. Recent data from the investigators and others has highlighted pregnancy as a unique, early moment of cardiovascular stress in young women that may "unmask" CVD propensity. It is unclear if PreE simply represents a "failed stress test" or directly contributes to the pathophysiology of future CVD. While mechanistic studies have largely been the purview of model-based studies, endothelial dysfunction has emerged as central to the pathogenesis of both PreE and peripartum cardiac dysfunction. Indeed, biomarkers of endothelial dysfunction and angiogenic imbalance during pregnancy have been shown to remain elevated at least 6 months post-partum. Moreover, peri-partum endothelial dysfunction can persist for years post-delivery and remains a significant risk factor for CVD (even after adjustment for other traditional risk factors). While these findings suggest that PreE-associated endothelial dysfunction and inflammation may contribute to early myocardial dysfunction that presages HF risk decades before its onset, the modifiable epidemiology of PreE-associated LVDD, including potential mechanisms of risk, remains unclear, limited by lack of precision molecular phenotypes accessible in a large number of American women across race. Ultimately, understanding the epidemiology and pathobiology of PreE-associated myocardial dysfunction affords a unique opportunity to identify women at risk with a longer lead-time for risk factor modification to interrupt CVD. The investigators hypothesize that persistent structural-functional myocardial alterations after PreE are linked to pre- and post-gravid cardiometabolic risk factors (SA1), functional and hemodynamic impairment (SA2) and select pathways of vascular and inflammatory stress relevant to HF risk (SA3). Despite extensive study on the role of inflammation/ischemia in PreE, there have been no large studies connecting these phenotypes with early PP functional response and biochemical alterations, a key barrier to designing studies for improving CVD/HF in women. SA1: To identify pregnancy-specific clinical factors related to postpartum HFpEF phenotypes Clinical Implication: Improve identification of women at highest risk for developing post-PreE LV diastolic dysfunction (a harbinger of HFpEF). SA2: To define functional and hemodynamic signatures of early HFpEF due to preeclampsia Clinical Implication: Identify women at highest risk for developing early HFpEF. SA3: To identify shared pathophysiologic mechanistic pathways for PreE-associated HFpEF Clinical Implication: Identify targetable pathways for post-PreE cardiac dysfunction that may prevent/ delay HFpEF development.
Eligibility 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.
Contact & Investigator
Kathryn Lindley, MD, FACC
PRINCIPAL INVESTIGATOR
VUMC
Frequently Asked Questions
Who can join the NCT06741436 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06741436 currently recruiting?
Yes, NCT06741436 is actively recruiting participants. Contact the research team at olivia.h.patridge@vumc.org for enrollment information.
Where is the NCT06741436 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06741436 clinical trial?
NCT06741436 is sponsored by Vanderbilt University Medical Center. The principal investigator is Kathryn Lindley, MD, FACC at VUMC. The trial plans to enroll 500 participants.