Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia

NCT04063397 | Completed

• 1 other identifier: 2018H0312
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia Severe or Mild; Cardiac Complication

Outcome Measures

Primary Outcomes (1)

• Cardiac dysfunction

  The following parameters will be measured to assess cardiac dysfunction: 1. LV Size/function 1. Biplane Method of Disks LVEF (a4C and 2C views for EDV and ESV) 2. LV Fractional shortening- Septal thickness and PW thickness 3. LV Strain- Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain 4. 3D LV EF 5. Tei index 6. Analysis of LV diastolic function- Mitral E wave, Mitral A wave, Mitral e', Mitral E/e', Mitral E/A and Mitral Decel time 2. LA volume 3. RA volume 4. IVC size/compressibility with inspiration 5. RV size/function 1. RV length 2. RV basal width 3. RV FAC % 4. TAPSE 5. S' 6. Tei index 7. TR velocity 8. RVSP 9. TAPSE 10. Longitudinal strain- Basal Longi, Basal longitudinal, Mid LV longitudinal, Apical LV longitudinal and Global LV longitudinal strain 6. Basic valve assessment

  From delivery up to 3-6 months postpartum

Study Arms (2)

Preeclampsia

40 patients diagnosed with preeclampsia with or without severe features

Diagnostic Test: Echocardiogram; Diagnostic Test: Blood draw

Control

20 Control group of patients without hypertensive disorders of pregnancy

Diagnostic Test: Echocardiogram; Diagnostic Test: Blood draw

Interventions

Echocardiogram DIAGNOSTIC_TEST

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

Control; Preeclampsia

Blood draw DIAGNOSTIC_TEST

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

Control; Preeclampsia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Echocardiography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Maternal-Fetal Medicine

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: August 19, 2019
• Primary Completion: January 30, 2023
• Study Completion: December 14, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

US (1)