Clinical trial NCT03014791: Influence of Age, Weight and Ethnic Background on Blood Pressure
Official title: Influence of Age, Weight and Ethnic Background on Blood Pressure: AWE Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2017-01-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients for this study will be identified in a secondary care setting from hypertension clinics at Cambridge University Hospitals, from two on-going observational community-based cohort studies - CLEAREST and ACCT, in addition to potential participants (healthy volunteers) who respond to recruitment posters displayed around Cambridge University Hospitals and the University of Cambridge.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiac Output (Measured by the inert gas re-breathing technique L/Min)
timeFrame: 5 years
measure: Peripheral vascular resistance (Calculated using Cardiac Output and Blood pressure data dynes/sec/cm^5 )
timeFrame: 5 years
measure: Pulse wave velocity (Measured by ECG-gated applanation tonometry meters/sec)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Vascular Research Clinic, Addenbrooke's Hospital
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge
name: Carmel McEniery, PhD
role: PRINCIPAL_INVESTIGATOR
References: