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Clinical Trials/NCT02103231
NCT02103231
Completed
Not Applicable

Young Adult Cardiovascular Health sTudy

University of Oxford1 site in 1 country149 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
University of Oxford
Enrollment
149
Locations
1
Primary Endpoint
Cardiopulmonary Exercise Capacity
Status
Completed
Last Updated
8 years ago

Overview

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.

Detailed Description

Young adults with a history of preterm birth are identified as having a unique risk profile for developing hypertension and having reduced exercise capacity. Globally, there are 15 million annual preterm births. In Europe, incidence is 6-15% of all births, with up to 6 million adults in the United Kingdom having a preterm birth history. Understanding the associations between early life exposures and this early cardiovascular risk is extremely important to be able to target primary prevention strategies. As yet there are no clear explanations for the reduced exercise capacity and elevated risk of hypertension reported in preterm born young adults. Magnetic resonance imaging studies of young adult born premature demonstrated altered heart shape, with increased left ventricular mass, reduced cavity sizes and reduced stroke volumes. The changes in cardiac size identified from these studies is similar to those seen in other disease groups and has been equated to greater than 50% increased risk of cardiovascular clinical events in these groups. These structural changes may account for the reduced exercise capacity observed in preterm born young adults This study aims to understand the physiological determinants of limited exercise capacity and associated cardiovascular risk profile of adult preterm born populations.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
May 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Cardiopulmonary Exercise Capacity

Time Frame: Single measure, baseline study recruitment

Peak oxygen uptake measured via cardiopulmonary exercise testing

Secondary Outcomes

  • Cardiac Function(Single measure, baseline recruitment)
  • Brain structure(Second study visit within 6 months of recruitment)
  • Vascular function(Single measure, baseline recruitment)
  • Cardiac Structure(Single measure, baseline recruitment)
  • Liver Structure(Single measure, baseline recruitment)
  • Dynamic cardiac function(Single measure, baseline recruitment)

Study Sites (1)

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