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临床试验/NCT02103231
NCT02103231已完成不适用

Young Adult Cardiovascular Health sTudy

University of Oxford1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
1
主要终点
Cardiopulmonary Exercise Capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Cardiopulmonary Exercise Capacity

时间窗: Single measure, baseline study recruitment

Peak oxygen uptake measured via cardiopulmonary exercise testing

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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