Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia

NCT ID: NCT04063397

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2023-12-14

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Preeclampsia

40 patients diagnosed with preeclampsia with or without severe features

Echocardiogram

Intervention Type: DIAGNOSTIC_TEST

Serial echocardiograms will be done on all patients pre-delivery, and at 3-6 months

Blood draw

Intervention Type: DIAGNOSTIC_TEST

Serial blood draws at same time points as echocardiograms for biomarker levels

Control

20 Control group of patients without hypertensive disorders of pregnancy

Echocardiogram

Intervention Type: DIAGNOSTIC_TEST

Serial echocardiograms will be done on all patients pre-delivery, and at 3-6 months

Blood draw

Intervention Type: DIAGNOSTIC_TEST

Serial blood draws at same time points as echocardiograms for biomarker levels

Interventions

Echocardiogram

Serial echocardiograms will be done on all patients pre-delivery, and at 3-6 months

Intervention Type: DIAGNOSTIC_TEST

Blood draw

Serial blood draws at same time points as echocardiograms for biomarker levels

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Females older than 18 years of age
• Singleton pregnancy
• The patient is physically and mentally able to understand the informed consent and is willing to participate in this study
• Able to speak English
• Must meet one of the population categories, until each group has reached 20 subjects

Exclusion Criteria

• Multiple gestation
• History of chronic hypertension or cardiac disease including but not limited to history of heart arrhythmias, congenital heart disease, and use of any cardiac medication (such as beta blockers, ACE inhibitors, calcium channel blockers) prior to pregnancy.
• History of medical problems that may contribute to cardiac dysfunction, including but not limited to chronic hypertension, poorly controlled hyperthyroidism and diabetes mellitus.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Kara M Rood, MD

Assistant Professor, Maternal-Fetal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2018H0312

Identifier Type: -

Identifier Source: org_study_id