The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health (EPOCH)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Paul Leeson, PhD, FRCP
- Número de teléfono: +44(0)1865572846
- Correo electrónico: paul.leeson@cardiov.ox.ac.uk
Ubicaciones de estudio
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Oxfordshire
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Oxford, Oxfordshire, Reino Unido, OX3 9DU
- Reclutamiento
- Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
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Contacto:
- Paul Leeson, PhD, MRCP
- Correo electrónico: paul.leeson@cardiov.ox.ac.uk
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Investigador principal:
- Paul Leeson, PhD, FRCP
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Normotensive Term
Infants born at term (>37 weeks) to Normotensive pregnancies
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Term Preeclampsia
Infants born at term (>37 weeks gestation) and exposed to a preeclamptic pregnancy
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Preterm Normotensive
Infants born to Normotensive pregnancies at <37 weeks gestation
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Preterm Hypertensive
Infants born to hypertensive pregnancies at <37 weeks completed gestation
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Term Pregnancy-induced Hypertension
Infants born at term (>37 weeks gestation) and exposed to pregnancy-induced hypertension
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Systolic Cardiac Function
Periodo de tiempo: Birth and 3 months
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Cardiac Function will be assessed by ECHO at birth and 3 months
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Birth and 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Micro-vascular Structure
Periodo de tiempo: Birth and 3 months
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Micro-vascular Structure will be assessed using Side Stream Dark Field (SDF) imaging device at birth and 3 months (as capillary density at baseline)
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Birth and 3 months
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Pulse wave velocity and pulse-wave analysis
Periodo de tiempo: Birth and 3 months
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Birth and 3 months
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Cardiac Structure
Periodo de tiempo: Birth and 3 months
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Cardiac structure will be assessed by echocardiography at in utero, at birth and 3 months (as left and right ventricular mass)
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Birth and 3 months
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Cardiac diastolic function
Periodo de tiempo: Birth and 3 months
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Cardiac Function will be assessed by ECHO at birth and 3 months
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Birth and 3 months
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Blood pressure
Periodo de tiempo: Birth and 3 months
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Birth and 3 months
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Heart rate variability
Periodo de tiempo: Birth and 3 months
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Heart rate variability will be assessed by a 5 minute electrocardiogram
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Birth and 3 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paul Leeson, PhD, FRCP, University of Oxford Department of Cardiovascular Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EPOCH
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