Young Adult Cardiovascular Health sTudy (YACHT)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Preterm Birth

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 Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Oxford, England, United Kingdom, OX39DU
      • Adam Lewandowski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Full Term Birth; History of full term birth (>37 weeks gestation) including sub-group with diagnosis of hypertension
Preterm Birth; History of preterm birth (<37 weeks gestation) including subgroup with diagnosis of hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary Exercise Capacity	Peak oxygen uptake measured via cardiopulmonary exercise testing	Single measure, baseline study recruitment

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Behaviour	Objective measure of physical activity using wrist worn accelerometer	Baseline recruitment
Ambulatory Blood Pressure	24 hour ambulatory blood pressure	Baseline Recruitment
Heart rate variability	24 hour heart rate variability	Baseline measure
Microvascular measures	Capillary density measured using microscopy	Single measure, baseline recruitment

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: British Heart Foundation
• Investigators: Principal Investigator: Paul Leeson, PhD, FRCP, University of Oxford Division of Cardiovascular Medicine; Study Director: Adam J Lewandowski, DPhil, University of Oxford Division of Cardiovascular Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Hypertension; Cardiovascular risk; Preterm birth; Exercise capacity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Hypertension; Premature Birth
• Other Study ID Numbers: YACHT