Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cindy Anderson, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01682304
First received: September 5, 2012
Last updated: September 22, 2013
Last verified: September 2013
  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 USDA Grand Forks Human Nutrition Research Center:

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.


Estimated Enrollment: 80
Study Start Date: May 2012
Estimated 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, North Dakota
USDA Grand Forks Human Research Nutrition Center
Grand Forks, North Dakota, United States, 58203
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: Cindy Anderson, PhD, WHNP-BC, FAAN, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01682304     History of Changes
Other Study ID Numbers: GFHNRC611
Study First Received: September 5, 2012
Last Updated: September 22, 2013
Health Authority: United States: Federal Government

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
preeclampsia
hypertension
blood pressure
pregnancy induced hypertension
chronic hypertension

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

ClinicalTrials.gov processed this record on July 26, 2014