Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia

Cardiac Complication Clinical Trial

— ECHO  

Official title:

Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063397
• Other study ID #: 2018H0312
• Status: Completed
• Start date: August 19, 2019
• Est. completion date: December 14, 2023

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 14, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Complication
• Pre-Eclampsia
• Preeclampsia Severe or Mild

Intervention

Diagnostic Test:
• Echocardiogram
Serial echocardiograms will be done on all patients pre-delivery, and at 3-6 months
• Blood draw
Serial blood draws at same time points as echocardiograms for biomarker levels

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Roche Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac dysfunction	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	From delivery up to 3-6 months postpartum