Young Adult Cardiovascular Health sTudy

Completed

• Conditions: Preterm Birth; Hypertension

• Registration Number: NCT02103231
• Lead Sponsor: University of Oxford

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.

Study Timeline

• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Study Start: 2014-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary Exercise Capacity	Single measure, baseline study recruitment	Peak oxygen uptake measured via cardiopulmonary exercise testing

Secondary Outcome Measures

Name	Time	Method
Cardiac Function	Single measure, baseline recruitment	Cardiac function measured via cardiac magnetic resonance imaging
Brain structure	Second study visit within 6 months of recruitment	Brain structure measured via magnetic resonance imaging
Vascular function	Single measure, baseline recruitment	Vascular function measured via pulse wave velocity
Cardiac Structure	Single measure, baseline recruitment	Cardiac structure measured via cardiac magnetic resonance imaging
Liver Structure	Single measure, baseline recruitment	Hepatic structure measured via magnetic resonance imaging
Dynamic cardiac function	Single measure, baseline recruitment	Dynamic cardiac function measured using echocardiogram during exercise

Trial Locations

Locations (1)

Adam Lewandowski; 🇬🇧 Oxford, England, United Kingdom