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

Preterm Birth Clinical Trial

— EPOCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01888770
• Other study ID #: EPOCH
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2013
• Last updated: May 23, 2016
• Start date: August 2011
• Est. completion date: September 2017

Study information

• Verified date: May 2016
• Source: University of Oxford
• Contact: Paul Leeson, PhD, FRCP
• Phone: +44(0)1865572846
• Email: paul.leeson[@]cardiov.ox.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications
• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
United Kingdom	Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Cardiac Function	Cardiac Function will be assessed by ECHO at birth and 3 months	Birth and 3 months	No
Secondary	Micro-vascular Structure	Micro-vascular Structure will be assessed using Side Stream Dark Field (SDF) imaging device at birth and 3 months (as capillary density at baseline)	Birth and 3 months	No
Secondary	Pulse wave velocity and pulse-wave analysis		Birth and 3 months	No
Secondary	Cardiac Structure	Cardiac structure will be assessed by echocardiography at in utero, at birth and 3 months (as left and right ventricular mass)	Birth and 3 months	No
Secondary	Cardiac diastolic function	Cardiac Function will be assessed by ECHO at birth and 3 months	Birth and 3 months	No
Secondary	Blood pressure		Birth and 3 months	No
Secondary	Heart rate variability	Heart rate variability will be assessed by a 5 minute electrocardiogram	Birth and 3 months	No