NCT02103231

Brief Summary

The purpose of this study is to understand more about why young people who were born prematurely may have increased risk of high blood pressure and lower cardiovascular exercise capacity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

March 31, 2014

Last Update Submit

February 22, 2018

Conditions

Preterm BirthHypertension

Keywords

Preterm birthHypertensionExercise capacityCardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary Exercise Capacity

    Peak oxygen uptake measured via cardiopulmonary exercise testing

    Single measure, baseline study recruitment

Secondary Outcomes (6)

  • Cardiac Structure

    Single measure, baseline recruitment

  • Cardiac Function

    Single measure, baseline recruitment

  • Liver Structure

    Single measure, baseline recruitment

  • Brain structure

    Second study visit within 6 months of recruitment

  • Vascular function

    Single measure, baseline recruitment

  • +1 more secondary outcomes

Other Outcomes (4)

  • Physical Activity Behaviour

    Baseline recruitment

  • Ambulatory Blood Pressure

    Baseline Recruitment

  • Heart rate variability

    Baseline measure

  • +1 more other outcomes

Study Arms (2)

Full Term Birth

History of full term birth (\>37 weeks gestation) including sub-group with diagnosis of hypertension

Preterm Birth

History of preterm birth (\<37 weeks gestation) including subgroup with diagnosis of hypertension

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults aged between 18 and 40 years old, recruited from the local community and Oxford University Hospitals Hypertension clinic, participants will have a history of preterm (\<37 weeks) or full term (\>37 weeks) birth.

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 to 40 years.
  • History of preterm birth, diagnosis of hypertension or full term birth normotensive control
  • Able (in the investigator's opinion) and willing to comply with all study requirements.
  • Participant is freely able to access John Radcliffe Hospital for study visits

You may not qualify if:

  • Aged \<18 years \>40 years
  • Unwilling or unable to give informed consent for participation in the study.
  • Pregnant or lactating during the course of the study.
  • Planning to donate blood during the study duration.
  • Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study.
  • Contraindication to Magnetic Resonance Imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adam Lewandowski

Oxford, England, OX39DU, United Kingdom

Location

Related Publications (2)

  • Mohamed A, Lamata P, Williamson W, Alsharqi M, Tan CMJ, Burchert H, Huckstep OJ, Suriano K, Francis JM, Pelado JL, Monteiro C, Neubauer S, Levy PT, Leeson P, Lewandowski AJ. Multimodality Imaging Demonstrates Reduced Right-Ventricular Function Independent of Pulmonary Physiology in Moderately Preterm-Born Adults. JACC Cardiovasc Imaging. 2020 Sep;13(9):2046-2048. doi: 10.1016/j.jcmg.2020.03.016. Epub 2020 May 13. No abstract available.

    PMID: 32417327DERIVED

  • Huckstep OJ, Williamson W, Telles F, Burchert H, Bertagnolli M, Herdman C, Arnold L, Smillie R, Mohamed A, Boardman H, McCormick K, Neubauer S, Leeson P, Lewandowski AJ. Physiological Stress Elicits Impaired Left Ventricular Function in Preterm-Born Adults. J Am Coll Cardiol. 2018 Mar 27;71(12):1347-1356. doi: 10.1016/j.jacc.2018.01.046.

    PMID: 29566820DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Premature BirthHypertension

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Paul Leeson, PhD, FRCP

    University of Oxford Division of Cardiovascular Medicine

    PRINCIPAL INVESTIGATOR

  • Adam J Lewandowski, DPhil

    University of Oxford Division of Cardiovascular Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

GB(1)