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The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health (EPOCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888770
Recruitment Status : Unknown
Verified May 2016 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : June 28, 2013
Last Update Posted : May 25, 2016
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date June 13, 2013
First Posted Date June 28, 2013
Last Update Posted Date May 25, 2016
Study Start Date August 2011
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2016)
Systolic Cardiac Function [ Time Frame: Birth and 3 months ]
Cardiac Function will be assessed by ECHO at birth and 3 months
Original Primary Outcome Measures
 (submitted: June 25, 2013)
Cardiac Function [ Time Frame: Birth and 3 months ]
Cardiac Structure will be assessed by ECHO at birth and 3 months
Change History
Current Secondary Outcome Measures
 (submitted: May 23, 2016)
  • Micro-vascular Structure [ Time Frame: Birth and 3 months ]
    Micro-vascular Structure will be assessed using Side Stream Dark Field (SDF) imaging device at birth and 3 months (as capillary density at baseline)
  • Pulse wave velocity and pulse-wave analysis [ Time Frame: Birth and 3 months ]
  • Cardiac Structure [ Time Frame: Birth and 3 months ]
    Cardiac structure will be assessed by echocardiography at in utero, at birth and 3 months (as left and right ventricular mass)
  • Cardiac diastolic function [ Time Frame: Birth and 3 months ]
    Cardiac Function will be assessed by ECHO at birth and 3 months
  • Blood pressure [ Time Frame: Birth and 3 months ]
  • Heart rate variability [ Time Frame: Birth and 3 months ]
    Heart rate variability will be assessed by a 5 minute electrocardiogram
Original Secondary Outcome Measures
 (submitted: June 25, 2013)
  • Micro-vascular Structure [ Time Frame: Birth and 3 months ]
    Micro-vascular Structure will be assessed using Side Stream Dark Field (SDF) imaging device at birth and 3 months
  • Micro-vascular function [ Time Frame: Birth and 3 months ]
    Micro-vascular Function will be assessed using using Side Stream Dark Field (SDF) imaging device at birth and 3 months
  • Pulse wave velocity and pulse-wave analysis [ Time Frame: Birth and 3 months ]
  • Cardiac Structure [ Time Frame: Birth and 3 months ]
    Cardiac structure will be assessed by echocardiography at birth and 3 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 25, 2013)
  • Blood Pressure [ Time Frame: Birth and 3 months ]
    Blood pressure will be assessed at birth and 3months
  • Macrovascular structure [ Time Frame: Birth to 3 months ]
    Macrovascular structure will be assessed by ultrasound at birth and 3 months
 
Descriptive Information
Brief Title The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
Official Title The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
Brief Summary The purpose of this study is to investigate whether exposure to hypertensive disorders of pregnancy and/or a preterm birth results in alterations in the cardiovascular system during infancy.
Detailed Description

While the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the United Kingdom. Identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. There is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term.

The investigators have therefore designed the EPOCH study to investigate whether those individuals born to hypertensive pregnancies and/or to a preterm birth demonstrate differences in the cardiovascular phenotype at birth, or whether they develop any differences over the first three months of life and whether this varies with other perinatal factors. This study also allows investigation of the short term impact of perinatal interventions used in this cohort. Comprehensive multi-modality non-invasive imaging measures of cardiovascular structure and function allow precise quantification of cardiovascular phenotype in this population.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum, plasma
Sampling Method Non-Probability Sample
Study Population Study population is drawn from infants admitted to or delivered in the OUH NHS Foundation trust to normotensive or hypertensive pregnancies across a range of gestations. The mothers of these infants form a secondary study cohort.
Condition
  • Preeclampsia
  • Preterm Birth
Intervention Not Provided
Study Groups/Cohorts
  • Normotensive Term
    Infants born at term (>37 weeks) to Normotensive pregnancies
  • Term Preeclampsia
    Infants born at term (>37 weeks gestation) and exposed to a preeclamptic pregnancy
  • Preterm Normotensive
    Infants born to Normotensive pregnancies at <37 weeks gestation
  • Preterm Hypertensive
    Infants born to hypertensive pregnancies at <37 weeks completed gestation
  • Term Pregnancy-induced Hypertension
    Infants born at term (>37 weeks gestation) and exposed to pregnancy-induced hypertension
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 Unknown status
Estimated Enrollment
 (submitted: May 23, 2016)
300
Original Estimated Enrollment
 (submitted: June 25, 2013)
200
Estimated Study Completion Date September 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Available for assessment within the neonatal period,
  • Parent is willing and able to give informed consent for participation in the study,
  • Physical condition is suitable to allow non-invasive vascular testing,
  • Mother meets criteria for inclusion in the study and is willing to participate in the study. (Aged >/= 16 years and Is able and willing to give informed consent for participation in the study, and is able and willing to give informed consent for her infants participation in the study. )
  • Cases: Diagnosed during pregnancy with preeclampsia or gestational hypertension and/or delivered preterm (<37 weeks gestation)
  • Controls: No history of gestational hypertension or preeclampsia during this pregnancy and delivered at term (>37 weeks gestation)

Exclusion Criteria:

  • Parent is unwilling to give consent,
  • Unavailable for assessment of cardiovascular system,
  • Physical condition unsuitable to allow for non-invasive testing of cardiovascular system,
  • Evidence of congenital cardiovascular disease (with the exception of Persistent Patent Ductus Arterious (PDA) and Atrial Septal Defect (ASD)),
  • Cardiorespiratory instability at time of proposed measures,
  • Active infection at time of proposed study measures,
  • Mother of infant is excluded from the study. (Aged <16 years, unable or unwilling to consent to study or Physical condition post delivery such that it would preclude participation in the study)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 6 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01888770
Other Study ID Numbers EPOCH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Oxford
Study Sponsor University of Oxford
Collaborators British Heart Foundation
Investigators
Principal Investigator: Paul Leeson, PhD, FRCP University of Oxford Department of Cardiovascular Medicine
PRS Account University of Oxford
Verification Date May 2016