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Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension

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ClinicalTrials.gov Identifier: NCT01682304
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Cindy Anderson, Ohio State University

Tracking Information
First Submitted Date September 5, 2012
First Posted Date September 10, 2012
Last Update Posted Date April 24, 2015
Study Start Date May 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2013)
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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01682304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 22, 2013)
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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension
Official Title Observational Study of Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension
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

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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Sputum and peripheral blood will be collected for DNA extraction and epigenetic analyses.
Sampling Method Probability Sample
Study Population Females diagnosed with chronic hypertension with a prior pregnancy
Condition
  • Preeclampsia
  • Hypertension
  • Pregnancy Induced Hypertension
Intervention Not Provided
Study Groups/Cohorts History of Preeclampsia
Chronic hypertension with history of preeclampsia Chronic hypertension without history of preeclampsia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 7, 2014)
12
Original Estimated Enrollment
 (submitted: September 5, 2012)
80
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01682304
Other Study ID Numbers GFHNRC611
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cindy Anderson, Ohio State University
Study Sponsor Ohio State University
Collaborators Not Provided
Investigators
Principal Investigator: Cindy M Anderson, PhD Ohio State University
PRS Account Ohio State University
Verification Date April 2015