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Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia (ECHO)

The Ohio State University logo

The Ohio State University

Status

Completed

Conditions

Cardiac Complication
Preeclampsia Severe or Mild

Treatments

Diagnostic Test: Echocardiogram
Diagnostic Test: Blood draw

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04063397
2018H0312

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

27 participants in 2 patient groups

Preeclampsia
Description:
40 patients diagnosed with preeclampsia with or without severe features
Treatment:
Diagnostic Test: Echocardiogram
Diagnostic Test: Blood draw
Control
Description:
20 Control group of patients without hypertensive disorders of pregnancy
Treatment:
Diagnostic Test: Echocardiogram
Diagnostic Test: Blood draw

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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