Young Adult Cardiovascular Health sTudy

NCT ID: NCT02103231

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Preterm Birth; Hypertension

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Full Term Birth

History of full term birth (\>37 weeks gestation) including sub-group with diagnosis of hypertension

No interventions assigned to this group

Preterm Birth

History of preterm birth (\<37 weeks gestation) including subgroup with diagnosis of hypertension

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Leeson, PhD, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Oxford Division of Cardiovascular Medicine

Adam J Lewandowski, DPhil

Role: STUDY_DIRECTOR

University of Oxford Division of Cardiovascular Medicine

Locations

Adam Lewandowski

Oxford, England, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32417327 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29566820 (View on PubMed)

Other Identifiers

YACHT

Identifier Type: -

Identifier Source: org_study_id