NCT04063397

Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes.

Detailed description

Preeclampsia (PE) is a multi-system progressive disorder affecting up to 8% of pregnancies. Epidemiologic studies have shown a significant association between PE and future cardiovascular disease (CVD) in women. Despite recognition of this relationship, there are no good markers to help determine which women are at highest risk, in particular as this relates to long-term cardiovascular risk, the number one cause of mortality in U.S. born women. As such, the study of PE and cardiovascular outcomes, in particular to identify early markers for the development of late CVD, provide insight into critical opportunities for early treatment and modification of disease trajectory in women. The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes. The investigators hypothesize that preeclampsia with severe features confers a much higher risk of cardiovascular impairment compared to milder form of preeclampsia and healthy controls. If the hypothesis proves correct, these findings may change clinical practice by warranting routine echocardiogram for these patients for early recognition, intervention and treatment of cardiac dysfunction.

Conditions

• Preeclampsia Severe or Mild
• Cardiac Complication

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiogram	Serial echocardiograms will be done on all patients pre-delivery, and at 3-6 months
DIAGNOSTIC_TEST	Blood draw	Serial blood draws at same time points as echocardiograms for biomarker levels

Timeline

• Start date: 2019-08-19
• Primary completion: 2023-01-30
• Completion: 2023-12-14
• First posted: 2019-08-21
• Last updated: 2024-01-10

Locations

1 site across 1 country: United States