No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
500 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for women over 18 who gave birth at VUMC and have been diagnosed with preeclampsia. Participants will help researchers understand cardiovascular health after pregnancy.
I have ongoing symptoms from a prior COVID-19 infection.
I have HIV.
I have hepatitis B or C.
I have pulmonary arterial hypertension.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 propens…
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.
Trial Locations
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Status
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-1…
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.
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