NCT01682304

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

1.8 years

First QC Date

September 5, 2012

Last Update Submit

October 10, 2022

Conditions

Keywords

preeclampsiahypertensionblood pressurepregnancy induced hypertensionchronic hypertension

Outcome Measures

Primary Outcomes (1)

  • DNA methylation pattern

    Determine DNA methylatiion patterns in women with hypertension who have/have not had a prior diagnosis of preeclampsia

    age 30-65

Secondary Outcomes (1)

  • Vascular function

    aged 30-65

Study Arms (1)

History of Preeclampsia

Chronic hypertension with history of preeclampsia Chronic hypertension without history of preeclampsia

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Females diagnosed with chronic hypertension with a prior pregnancy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum and peripheral blood will be collected for DNA extraction and epigenetic analyses.

MeSH Terms

Conditions

Pre-EclampsiaHypertensionHypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Cindy M Anderson, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, WHNP-BC, FAAN

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 10, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations