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Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01682304
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : April 24, 2015
Information provided by (Responsible Party):
Cindy Anderson, Ohio State University

Brief Summary:

Preliminary data from the investigator's lab identified novel patterns of differential DNA methylation in genes regulating cardiovascular and metabolic function in blood from women during the first trimester of pregnancy who were destined to develop preeclampsia (PE) in the third trimester. Further, common patterns of differential DNA methylation were found in the common genes from placental tissue at time of birth in the same women after diagnosis with PE, suggesting that the epigenomic patterns that predict pregnancy-induced hypertension may also underlie the development of chronic hypertension years after.

It is unknown whether aberrant DNA methylation in pregnancy-induced hypertension is the mechanism by which chronic hypertension develops in these women remote from pregnancy nor is it known if hypertension remote from PE is as responsive to therapeutic treatment of hypertension compared to women who develop hypertension without history of PE. The investigators plan to objectively test the central hypothesis and attain the objective of this project

Condition or disease
Preeclampsia Hypertension Pregnancy Induced Hypertension

Detailed Description:
Women comprise 51% of the total heart disease deaths in the United States (NC with an estimated economic cost expected to climb to more than $258 billion. Hypertension, a prevalent manifestation of early cardiovascular disease, is a silent condition that contributes to significant adverse health consequences. Preeclampsia (PE), a form of pregnancy-induced hypertension diagnosed in the second half of pregnancy, is now established as a non-modifiable risk factor for future development of hypertension. As PE carries a familial risk for future development of PE in female offspring, the implications of increased risk for PE-associated future development of chronic hypertension further compounds the significance of this unique cardiovascular risk. This raises an important health concern, though little is known about the mechanisms underlying risk of PE-associated future chronic hypertension. As epigenetic patterns of DNA methylation are associated with transfer across generations and are known to be dysregulated in PE, we propose to test the central hypothesis that differential DNA methylation patterns in key cardiovascular genes identified in women with PE serve as a biomarker and predictor for therapeutic responsiveness for the remote diagnosis and prognosis of chronic hypertension, respectively. Therefore, the purpose of this study is to identify distinct epigenetic patterns of DNA methylation associated with preeclampsia (PE) that underlie the future development of hypertension and to determine the implication on responses to moderators and therapeutic interventions in the management of chronic hypertension.Univariate analysis of variance will be used to test associations between DNA methylation in genes and chronic hypertension among women with and without a history of preeclampsia. We will use multiple linear regression to examine differences in treatment responses to high blood pressure based on DNA methylation patterns in candidate cardiovascular genes.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension
Study Start Date : May 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

History of Preeclampsia
Chronic hypertension with history of preeclampsia Chronic hypertension without history of preeclampsia

Primary Outcome Measures :
  1. DNA methylation pattern [ Time Frame: age 30-65 ]
    Determine DNA methylatiion patterns in women with hypertension who have/have not had a prior diagnosis of preeclampsia

Secondary Outcome Measures :
  1. Vascular function [ Time Frame: aged 30-65 ]
    Determine differences in vascular function among women aged 30-65, diagnosed with hypertension and who have/have not had a prior diagnosis of preeclampsia

Biospecimen Retention:   Samples With DNA
Sputum and peripheral blood will be collected for DNA extraction and epigenetic analyses.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Females diagnosed with chronic hypertension with a prior pregnancy

Inclusion Criteria:

  • Female gender
  • history of prior pregnancy
  • diagnosis of chronic hypertension
  • current treatment of chronic hypertension
  • age 30 - 50 years old

Exclusion Criteria:

  • presence of comorbid conditions that influence cardiovascular health (SLE, congenital cardiac anomalies

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 identifier (NCT number): NCT01682304

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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
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Principal Investigator: Cindy M Anderson, PhD Ohio State University

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Responsible Party: Cindy Anderson, PhD, WHNP-BC, FAAN, Ohio State University Identifier: NCT01682304     History of Changes
Other Study ID Numbers: GFHNRC611
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015
Keywords provided by Cindy Anderson, Ohio State University:
blood pressure
pregnancy induced hypertension
chronic hypertension
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications