Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cindy Anderson, Ohio State University
ClinicalTrials.gov Identifier:
NCT01682304
First received: September 5, 2012
Last updated: April 22, 2015
Last verified: April 2015
  Purpose

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
Preeclampsia
Hypertension
Pregnancy Induced Hypertension

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • DNA methylation pattern [ Time Frame: age 30-65 ] [ Designated as safety issue: No ]
    Determine DNA methylatiion patterns in women with hypertension who have/have not had a prior diagnosis of preeclampsia


Secondary Outcome Measures:
  • Vascular function [ Time Frame: aged 30-65 ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: May 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
History of Preeclampsia
Chronic hypertension with history of preeclampsia Chronic hypertension without history of preeclampsia

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Females diagnosed with chronic hypertension with a prior pregnancy

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01682304

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

No publications provided

Responsible Party: Cindy Anderson, PhD, WHNP-BC, FAAN, Ohio State University
ClinicalTrials.gov Identifier: NCT01682304     History of Changes
Other Study ID Numbers: GFHNRC611
Study First Received: September 5, 2012
Last Updated: April 22, 2015
Health Authority: United States: Federal Government

Keywords provided by Ohio State University:
preeclampsia
hypertension
blood pressure
pregnancy induced hypertension
chronic hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Cardiovascular Diseases
Pregnancy Complications
Vascular Diseases

ClinicalTrials.gov processed this record on July 30, 2015