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Trial record 36 of 147 for:    severe preeclampsia AND hypertensive disorders

Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia (ECHO)

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ClinicalTrials.gov Identifier: NCT04063397
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Roche Diagnostics
Information provided by (Responsible Party):
Kara M Rood, MD, Ohio State University

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.

Condition or disease Intervention/treatment
Preeclampsia Preeclampsia Severe Cardiac Complication 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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Persistent Postpartum Cardiovascular Dysfunction in Patients With Preeclampsia
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : August 19, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Group/Cohort Intervention/treatment
Preeclampsia with severe features
20 patients diagnosed with preeclampsia with severe features
Diagnostic Test: Echocardiogram
Serial echocardiograms will be done on all patients pre-delivery, and at 3 months, 6 months and 1 year postpartum

Diagnostic Test: Blood draw
Serial blood draws at same time points as echocardiograms for biomarker levels

Preeclampsia without severe features
20 patients diagnosed with preeclampsia without severe features
Diagnostic Test: Echocardiogram
Serial echocardiograms will be done on all patients pre-delivery, and at 3 months, 6 months and 1 year postpartum

Diagnostic Test: Blood draw
Serial blood draws at same time points as echocardiograms for biomarker levels

Control
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 months, 6 months and 1 year postpartum

Diagnostic Test: Blood draw
Serial blood draws at same time points as echocardiograms for biomarker levels




Primary Outcome Measures :
  1. Cardiac dysfunction [ Time Frame: From delivery up to 1 year postpartum ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
20 patients with preeclampsia with severe features 20 patients with preeclampsia without severe features 20 control group patients with no hypertensive disorder of pregnancy
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063397


Contacts
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Contact: Kara Rood, MD 614-293-8500 kara.rood@osumc.edu
Contact: Taryn Summerfield 614-293-2122 summerfield.7@osu.edu

Locations
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United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Kara Rood, MD    614-293-8500    kara.rood@osumc.edu   
Sponsors and Collaborators
Ohio State University
Roche Diagnostics

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Responsible Party: Kara M Rood, MD, Assistant Professor, Maternal-Fetal Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT04063397     History of Changes
Other Study ID Numbers: 2018H0312
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications