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

23. maj 2016 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Oxfordshire
      • Oxford, Oxfordshire, Det Forenede Kongerige, OX3 9DU
        • Rekruttering
        • Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
        • Kontakt:
        • Ledende efterforsker:
          • Paul Leeson, PhD, FRCP

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 6 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Oxford

Samarbejdspartnere

British Heart Foundation

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Forventet)

1. september 2017

Studieafslutning (Forventet)

1. september 2017

Datoer for studieregistrering

Først indsendt

13. juni 2013

Først indsendt, der opfyldte QC-kriterier

25. juni 2013

Først opslået (Skøn)

28. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EPOCH

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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