Preterm BirthYACHTNCT02103231
Young Adult Cardiovascular Health sTudy
An observational study of Preterm Birth and Hypertension, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Hypertension
- How many people
- 149 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- Preterm birth, Hypertension, Exercise capacity, Cardiovascular risk
- Medical subject headings
- Premature Birth, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Capacity
Peak oxygen uptake measured via cardiopulmonary exercise testing
Measured: Single measure, baseline study recruitment
Secondary outcomes (6)
Cardiac Structure
Cardiac structure measured via cardiac magnetic resonance imaging
Measured: Single measure, baseline recruitment
Cardiac Function
Cardiac function measured via cardiac magnetic resonance imaging
Measured: Single measure, baseline recruitment
Liver Structure
Hepatic structure measured via magnetic resonance imaging
Measured: Single measure, baseline recruitment
Brain structure
Brain structure measured via magnetic resonance imaging
Measured: Second study visit within 6 months of recruitment
Vascular function
Vascular function measured via pulse wave velocity
Measured: Single measure, baseline recruitment
Dynamic cardiac function
Dynamic cardiac function measured using echocardiogram during exercise
Measured: Single measure, baseline recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Paul Leeson, PhD, FRCP, Principal investigator, University of Oxford Division of Cardiovascular MedicineAdam J Lewandowski, DPhil, Study director, University of Oxford Division of Cardiovascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103231
- Sponsor's protocol ID
- YACHT
- Acronym
- YACHT
- Status last verified
- Feb 2018
- First submitted
- 31 Mar 2014
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Greggio J, Malamateniou C, Baruteau KP, Reyes-Aldasoro CC, Huckstep OJ, Francis JM, Williamson W, Leeson P, Lewandowski AJ, Lapidaire W. Distinct Circle of Willis anatomical configurations in healthy preterm born adults: a 3D time-of-flight magnetic resonance angiography study. BMC Med Imaging. 2025 Jan 30;25(1):33. doi: 10.1186/s12880-025-01562-y.
PubMed 39885378Mohamed 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.
PubMed 32417327Huckstep 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.
PubMed 29566820
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adult Cardiovascular Health sTudy
- ClinicalTrials.gov ID
- NCT02103231
- Acronym / sponsor ID
- YACHT / YACHT
- Conditions
- Preterm Birth, Hypertension
- Keywords
- Preterm birth, Hypertension, Exercise capacity, Cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- May 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiopulmonary Exercise Capacity
Time frame: Single measure, baseline study recruitment
Peak oxygen uptake measured via cardiopulmonary exercise testing
6 secondary outcomes
Cardiac Structure
Time frame: Single measure, baseline recruitment
Cardiac Function
Time frame: Single measure, baseline recruitment
Liver Structure
Time frame: Single measure, baseline recruitment
Brain structure
Time frame: Second study visit within 6 months of recruitment
Vascular function
Time frame: Single measure, baseline recruitment
Dynamic cardiac function
Time frame: Single measure, baseline recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Derived from this study: PubMed 39885378Greggio J, Malamateniou C, Baruteau KP, Reyes-Aldasoro CC, Huckstep OJ, Francis JM, Williamson W, Leeson P, Lewandowski AJ, Lapidaire W. Distinct Circle of Willis anatomical configurations in healthy preterm born adults: a 3D time-of-flight magnetic resonance angiography study. BMC Med Imaging. 2025 Jan 30;25(1):33. doi: 10.1186/s12880-025-01562-y.
- Derived from this study: PubMed 32417327Mohamed 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.
- Derived from this study: PubMed 29566820Huckstep 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Leeson, PhD, FRCP principal investigator
University of Oxford Division of Cardiovascular Medicine
Adam J Lewandowski, DPhil study director
University of Oxford Division of Cardiovascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Hypertension, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary Exercise Capacity (time frame: Single measure, baseline study recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02103231, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.