Skip to main content
OpenTrials
Completed

NCT Number: NCT04063397

Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echocardiogram

Diagnostic Test

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

Blood draw

Diagnostic Test

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

Primary outcomes

  1. Cardiac dysfunction

    Time frame: From delivery up to 3-6 months postpartum

    The following parameters will be measured to assess cardiac dysfunction:

    • LV Size/function
    • Biplane Method of Disks LVEF (a4C and 2C views for EDV and ESV)
    • LV Fractional shortening- Septal thickness and PW thickness
    • LV Strain- Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain
    • 3D LV EF
    • Tei index
    • Analysis of LV diastolic function- Mitral E wave, Mitral A wave, Mitral e', Mitral E/e', Mitral E/A and Mitral Decel time
    • LA volume
    • RA volume
    • IVC size/compressibility with inspiration
    • RV size/function
    • RV length
    • RV basal width
    • RV FAC %
    • TAPSE
    • S'
    • Tei index
    • TR velocity
    • RVSP
    • TAPSE
    • Longitudinal strain- Basal Longi, Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain
    • Basic valve assessment

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Acronym: ECHO

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2019
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.