Exercise Testing After Preeclampsia
Vanderbilt University Medical Center · NCT06741436
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · Women only
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 500
- US sites recruiting
- 1
- Study start
- February 18, 2025
- Record last updated
- April 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Conditions: Preeclampsia; Heart Failure Preserved Ejection Fraction; Hypertension
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Women age > 18 years
- Give birth at VUMC
- Have a diagnosis of PreE based on accepted American College of Obstetricians and Gynecologists criteria
Exclusion Criteria
- Age \<18 years old
- Unable to provide informed consent
- Does not speak English
- Active COVID-19 infection
- Residual symptoms related to prior COVID-19 infection
- HIV infection
- Hepatitis B or C infection
- Pulmonary arterial hypertension
- Sickle cell disease
- Pulmonary embolism
- Pre-existing cardiomyopathy
- Coronary artery disease
- Active substance abuse (other than tobacco or marijuana)
- Unable to attend postpartum visits
Controls
- 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.
Recruiting US locations
Vanderbilt University Medical Center
Nashville, TN 37203
Site contact: Kathryn Lindley, MD, FACC · 615-322-1710 · kathryn.lindley@vumc.org
Study contacts (from the official record)
- Olivia H Patridge, BS · 615-875-2942 · olivia.h.patridge@vumc.org
- Cassandra F Reynolds, BS, CCRC · 615-875-9854 · cassandra.f.reynolds@vumc.org
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