Clinical trial NCT02103231: Young Adult Cardiovascular Health sTudy
Official title: Young Adult Cardiovascular Health sTudy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Hypertension
Keywords: Preterm birth
Hypertension
Exercise capacity
Cardiovascular risk
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2014-04-03
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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

Primary outcomes:
measure: Cardiopulmonary Exercise Capacity
timeFrame: Single measure, baseline study recruitment
Secondary outcomes:
measure: Cardiac Structure
timeFrame: Single measure, baseline recruitment
measure: Cardiac Function
timeFrame: Single measure, baseline recruitment
measure: Liver Structure
timeFrame: Single measure, baseline recruitment
measure: Brain structure
timeFrame: Second study visit within 6 months of recruitment
measure: Vascular function
timeFrame: Single measure, baseline recruitment
measure: Dynamic cardiac function
timeFrame: Single measure, baseline recruitment
Other outcomes:
measure: Physical Activity Behaviour
timeFrame: Baseline recruitment
measure: Ambulatory Blood Pressure
timeFrame: Baseline Recruitment
measure: Heart rate variability
timeFrame: Baseline measure
measure: Microvascular measures
timeFrame: Single measure, baseline recruitment
Locations:
city: Oxford
country: United Kingdom
facility: Adam Lewandowski
state: England
Study officials:
affiliation: University of Oxford Division of Cardiovascular Medicine
name: Paul Leeson, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford Division of Cardiovascular Medicine
name: Adam J Lewandowski, DPhil
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.