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

23. mai 2016 oppdatert av: University of Oxford
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.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
    • Oxfordshire
      • Oxford, Oxfordshire, Storbritannia, OX3 9DU
        • Rekruttering
        • Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul Leeson, PhD, FRCP

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 6 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Systolic Cardiac Function
Tidsramme: Birth and 3 months
Cardiac Function will be assessed by ECHO at birth and 3 months
Birth and 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Micro-vascular Structure
Tidsramme: 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)
Birth and 3 months
Pulse wave velocity and pulse-wave analysis
Tidsramme: Birth and 3 months
Birth and 3 months
Cardiac Structure
Tidsramme: 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)
Birth and 3 months
Cardiac diastolic function
Tidsramme: Birth and 3 months
Cardiac Function will be assessed by ECHO at birth and 3 months
Birth and 3 months
Blood pressure
Tidsramme: Birth and 3 months
Birth and 3 months
Heart rate variability
Tidsramme: Birth and 3 months
Heart rate variability will be assessed by a 5 minute electrocardiogram
Birth and 3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Oxford

Samarbeidspartnere

British Heart Foundation

Etterforskere

  • Hovedetterforsker: Paul Leeson, PhD, FRCP, University of Oxford Department of Cardiovascular Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2011

Primær fullføring (Forventet)

1. september 2017

Studiet fullført (Forventet)

1. september 2017

Datoer for studieregistrering

Først innsendt

13. juni 2013

Først innsendt som oppfylte QC-kriteriene

25. juni 2013

Først lagt ut (Anslag)

28. juni 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EPOCH

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