Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension

This study is currently recruiting participants.

Verified March 2013 by USDA Grand Forks Human Nutrition Research Center

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: March 13, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 5, 2012
Last Updated Date	March 13, 2013
Start Date ^ICMJE	May 2012
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01682304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Epigenomic Dysregulation in Preeclampsia-Associated Chronic Hypertension
Official Title ^ICMJE	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	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	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 ^ICMJE	Preeclampsia Hypertension Pregnancy Induced Hypertension
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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 ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	80
Completion Date	Not Provided
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	30 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01682304
Other Study ID Numbers ^ICMJE	GFHNRC611
Has Data Monitoring Committee	Not Provided
Responsible Party	Cindy Anderson, USDA Grand Forks Human Nutrition Research Center
Study Sponsor ^ICMJE	USDA Grand Forks Human Nutrition Research Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	USDA Grand Forks Human Nutrition Research Center
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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