Influence of Age, Weight and Ethnic Background on Blood Pressure

Hypertension Clinical Trial

— AWE  

Official title:

Influence of Age, Weight and Ethnic Background on Blood Pressure: AWE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014791
• Other study ID #: AWE
• Status: Recruiting
• Start date: February 21, 2017
• Est. completion date: February 2024

Study information

• Verified date: August 2022
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Natalie Byrne
• Phone: 01223 349762
• Email: natalie.byrne[@]addenbrookes.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hypertension, also known as high blood pressure, is a chronic medical condition, in which the blood pressure is elevated. This is a common condition, which can lead to severe complications such as cardiovascular disease, heart attack, stroke and kidney disease, if not detected and treated early. Accumulating evidence suggests that the incidence of hypertension varies according to age, ethnicity and obesity. In order to obtain an in-depth knowledge of the pathophysiological mechanisms of hypertension, we aim to investigate the haemodynamic and biochemical correlates of elevated blood pressure across the adult age-span, and determine the extent to which body size and ethnicity impact on these associations. We also wish to investigate the impact of hypertension on key target organs (end-organ damage). The primary objective of this study is to compare the mechanisms regulating blood pressure in hypertensive and non-hypertensive participants across the adult age span, and to assess the influence of body mass index and ethnic background on these mechanisms. Secondary objectives are to investigate the association between blood pressure and cardiovascular physiology across the adult age span at rest and during sub-maximal exercise and to investigate the impact of blood pressure haemodynamics on key organs including the arteries and heart by assessing end-organ damage such as endothelial function, arterial structure and left ventricular mass/function. This study will be a combined case-control and cross-sectional study describing the procedures and time commitment required to investigate our scientific aims. This is a single centre study that will be conducted in a secondary care environment. Both male and females aged 18 and over and that are able provide informed consent will be considered for this study. People who are pregnant, currently receiving dialysis, illness with a life expectancy <1 year, current active malignancy and cannot provide informed consent are ineligible for this study. The study will be open for five years and each patient will complete a maximum of four visits in a 12 month period. Participants will complete a variety of non-invasive physiological assessments of their cardiovascular system and lung function. There will be some minimally invasive procedures completed, including a blood test and assessment of small artery endothelial function which involves insertion of a small needle under local anesthetic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or Female, aged 18 or above
• Able to give informed consent and willing to participate

Exclusion Criteria:

• Pregnancy
• Current active malignancy
• Currently receiving dialysis
• Any illness with a life expectancy < 1 year
• Lack of written informed consent

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

Other:
• Brief lifestyle/medical history questionnaire
Core Measurement
• Anthropometric measures
Core Measurement
• Blood pressure and arterial stiffness
Core Measurement
• Cardiac output and lung function
Core Measurement
• Heart rate variability
Core Measurement
• Blood sample & spot urine sample
Core Measurement
• 24 hour ambulatory blood pressure monitor
Detailed Measurement (Optional for participants).
• 24 hour urine collection
Detailed Measurement (Optional for participants).
• Echocardiograph: Left ventricular mass
Detailed Measurement (Optional for participants).
• Large artery structure: Carotid intima-media thickness
Detailed Measurement (Optional for participants).
• Small artery structure: Minimum forearm vascular resistance
Detailed Measurement (Optional for participants).
• Large artery endothelial function
Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
• Small artery endothelial function: Forearm blood flow
Detailed Measurement (Optional for participants).
• Dundee step test
Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
• Detailed haemodynamic response to submaximal exercise
Detailed Measurement (Optional for participants).
• Cardiopulmonary fitness: Maximum oxygen consumption
Detailed Measurement (Optional for participants).
• Haemodynamic response to mental stress
Detailed Measurement (Optional for participants).
• Small artery dilatory function: Forearm blood flow
Detailed Measurement (Optional for participants).

Locations

Country	Name	City	State
United Kingdom	Vascular Research Clinic, Addenbrooke's Hospital	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output (Measured by the inert gas re-breathing technique L/Min)		5 years
Primary	Peripheral vascular resistance (Calculated using Cardiac Output and Blood pressure data dynes/sec/cm^5 )		5 years
Primary	Pulse wave velocity (Measured by ECG-gated applanation tonometry meters/sec)		5 years