Young Adult Cardiovascular Health sTudy

Hypertension Clinical Trial

— YACHT  

Official title:

Young Adult Cardiovascular Health sTudy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103231
• Other study ID #: YACHT
• Status: Completed
• Phase: N/A
• First received: March 31, 2014
• Last updated: February 22, 2018
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: February 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
United Kingdom	Adam Lewandowski	Oxford	England

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity Behaviour	Objective measure of physical activity using wrist worn accelerometer	Baseline recruitment
Other	Ambulatory Blood Pressure	24 hour ambulatory blood pressure	Baseline Recruitment
Other	Heart rate variability	24 hour heart rate variability	Baseline measure
Other	Microvascular measures	Capillary density measured using microscopy	Single measure, baseline recruitment
Primary	Cardiopulmonary Exercise Capacity	Peak oxygen uptake measured via cardiopulmonary exercise testing	Single measure, baseline study recruitment
Secondary	Cardiac Structure	Cardiac structure measured via cardiac magnetic resonance imaging	Single measure, baseline recruitment
Secondary	Cardiac Function	Cardiac function measured via cardiac magnetic resonance imaging	Single measure, baseline recruitment
Secondary	Liver Structure	Hepatic structure measured via magnetic resonance imaging	Single measure, baseline recruitment
Secondary	Brain structure	Brain structure measured via magnetic resonance imaging	Second study visit within 6 months of recruitment
Secondary	Vascular function	Vascular function measured via pulse wave velocity	Single measure, baseline recruitment
Secondary	Dynamic cardiac function	Dynamic cardiac function measured using echocardiogram during exercise	Single measure, baseline recruitment