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Completed

NCT Number: NCT02103231

Young Adult Cardiovascular Health sTudy

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Adam Lewandowski

Oxford, England, OX39DU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cardiopulmonary Exercise Capacity

    Time frame: Single measure, baseline study recruitment

    Peak oxygen uptake measured via cardiopulmonary exercise testing

Secondary outcomes

  1. Cardiac Structure

    Time frame: Single measure, baseline recruitment

    Cardiac structure measured via cardiac magnetic resonance imaging

  2. Cardiac Function

    Time frame: Single measure, baseline recruitment

    Cardiac function measured via cardiac magnetic resonance imaging

  3. Liver Structure

    Time frame: Single measure, baseline recruitment

    Hepatic structure measured via magnetic resonance imaging

  4. Brain structure

    Time frame: Second study visit within 6 months of recruitment

    Brain structure measured via magnetic resonance imaging

  5. Vascular function

    Time frame: Single measure, baseline recruitment

    Vascular function measured via pulse wave velocity

  6. Dynamic cardiac function

    Time frame: Single measure, baseline recruitment

    Dynamic cardiac function measured using echocardiogram during exercise

Other outcomes

  1. Physical Activity Behaviour

    Time frame: Baseline recruitment

    Objective measure of physical activity using wrist worn accelerometer

  2. Ambulatory Blood Pressure

    Time frame: Baseline Recruitment

    24 hour ambulatory blood pressure

  3. Heart rate variability

    Time frame: Baseline measure

    24 hour heart rate variability

  4. Microvascular measures

    Time frame: Single measure, baseline recruitment

    Capillary density measured using microscopy

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • British Heart Foundation

Registry information

Acronym: YACHT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 3, 2014
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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