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Influence of Age, Weight and Ethnic Background on Blood Pressure

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03014791
Acronym
AWE
Enrollment
500
Registered
2017-01-09
Start date
2017-02-21
Completion date
2024-02-29
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Vascular Diseases, Hypertension

Keywords

Epidemiology, Ethnicity, Age, Weight, Hypertensive, Cardiac Output, Peripheral Vascular Resistance, Arterial Stiffness, Healthy Volunteers, Endothelial function, Arterial Structure, Left ventricular mass/function

Brief 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.

Interventions

OTHERBrief lifestyle/medical history questionnaire

Core Measurement

Core Measurement

OTHERBlood pressure and arterial stiffness

Core Measurement

OTHERCardiac output and lung function

Core Measurement

OTHERHeart rate variability

Core Measurement

OTHERBlood sample & spot urine sample

Core Measurement

OTHER24 hour ambulatory blood pressure monitor

Detailed Measurement (Optional for participants).

Detailed Measurement (Optional for participants).

OTHEREchocardiograph: Left ventricular mass

Detailed Measurement (Optional for participants).

OTHERLarge artery structure: Carotid intima-media thickness

Detailed Measurement (Optional for participants).

OTHERSmall artery structure: Minimum forearm vascular resistance

Detailed Measurement (Optional for participants).

OTHERLarge artery endothelial function

Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).

OTHERSmall artery endothelial function: Forearm blood flow

Detailed Measurement (Optional for participants).

OTHERDundee step test

Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).

OTHERDetailed haemodynamic response to submaximal exercise

Detailed Measurement (Optional for participants).

OTHERCardiopulmonary fitness: Maximum oxygen consumption

Detailed Measurement (Optional for participants).

OTHERHaemodynamic response to mental stress

Detailed Measurement (Optional for participants).

OTHERSmall artery dilatory function: Forearm blood flow

Detailed Measurement (Optional for participants).

Sponsors

University of Cambridge
CollaboratorOTHER
Cambridge University Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

United Kingdom

Contacts

Primary ContactNatalie Byrne
natalie.byrne@addenbrookes.nhs.uk01223 349762
Backup ContactCarmel McEniery, PhD
cmm41@medschl.cam.ac.uk01223 217564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026