Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia (ECHO)

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Complication; Preeclampsia Severe or Mild
• Intervention / Treatment: Diagnostic test: Echocardiogram; Diagnostic test: Blood draw

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

40 patients with preeclampsia with or without severe features 20 control group patients with no hypertensive disorder of pregnancy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preeclampsia; 40 patients diagnosed with preeclampsia with or without severe features	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
Control; 20 Control group of patients without hypertensive disorders of pregnancy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac dysfunction	The following parameters will be measured to assess cardiac dysfunction: LV Size/functionBiplane Method of Disks LVEF (a4C and 2C views for EDV and ESV)LV Fractional shortening- Septal thickness and PW thicknessLV Strain- Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain3D LV EFTei indexAnalysis 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/functionRV lengthRV basal widthRV FAC %TAPSES'Tei indexTR velocityRVSPTAPSELongitudinal strain- Basal Longi, Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain; Basic valve assessment	From delivery up to 3-6 months postpartum

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Roche Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia
• Other Study ID Numbers: 2018H0312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No