The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health (EPOCH)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Oxfordshire
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Oxford, Oxfordshire, Royaume-Uni, OX3 9DU
- Recrutement
- Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
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Contact:
- Paul Leeson, PhD, MRCP
- E-mail: paul.leeson@cardiov.ox.ac.uk
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Chercheur principal:
- Paul Leeson, PhD, FRCP
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Systolic Cardiac Function
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Micro-vascular Structure
Délai: 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
Délai: Birth and 3 months
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Birth and 3 months
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Cardiac Structure
Délai: 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
Délai: 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
Délai: Birth and 3 months
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Birth and 3 months
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Heart rate variability
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Paul Leeson, PhD, FRCP, University of Oxford Department of Cardiovascular Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EPOCH
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