Influence of Age, Weight and Ethnic Background on Blood Pressure (AWE)

August 21, 2022 updated by: Carmel McEniery, Cambridge University Hospitals NHS Foundation Trust

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Recruiting
        • Vascular Research Clinic, Addenbrooke's Hospital
        • Contact:
        • Principal Investigator:
          • Carmel McEniery, MPhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Volunteers

No IMP to be administered, only challenge agents as part of the physiological assessments.

Large artery endothelial function:

  • Glyceryl trinitrate 500 μg (Sublingual administration to stimulate endothelium-independent vasodilatation)
  • Salbutamol 2 x 200 μg (Administered by spacer device to stimulate endothelium-dependent vasodilatation)

Forearm blood flow

  • Acetylcholine: 7.5μg/min, 15μg/min and 30μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-dependent vasodilatation)
  • Sodium nitroprusside: 3μg/min, 10μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-independent vasodilatation)
  • LNMMA: 2μmol/min, 4μmol/min (Intra-arterial administration via brachial artery to block basal nitric oxide production)
Other: Brief lifestyle/medical history questionnaire
Core Measurement
Other: Anthropometric measures
Core Measurement
Other: Blood pressure and arterial stiffness
Core Measurement
Other: Cardiac output and lung function
Core Measurement
Other: Heart rate variability
Core Measurement
Other: Blood sample & spot urine sample
Core Measurement
Other: 24 hour ambulatory blood pressure monitor
Detailed Measurement (Optional for participants).
Other: 24 hour urine collection
Detailed Measurement (Optional for participants).
Other: Echocardiograph: Left ventricular mass
Detailed Measurement (Optional for participants).
Other: Large artery structure: Carotid intima-media thickness
Detailed Measurement (Optional for participants).
Other: Small artery structure: Minimum forearm vascular resistance
Detailed Measurement (Optional for participants).
Other: Large artery endothelial function
Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
Other: Small artery endothelial function: Forearm blood flow
Detailed Measurement (Optional for participants).
Other: Dundee step test
Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
Other: Detailed haemodynamic response to submaximal exercise
Detailed Measurement (Optional for participants).
Other: Cardiopulmonary fitness: Maximum oxygen consumption
Detailed Measurement (Optional for participants).
Other: Haemodynamic response to mental stress
Detailed Measurement (Optional for participants).
Other: Small artery dilatory function: Forearm blood flow
Detailed Measurement (Optional for participants).
Hypertensive Patients (Case-control)

No IMP to be administered, only challenge agents as part of the physiological assessments.

Large artery endothelial function:

  • Glyceryl trinitrate 500 μg (Sublingual administration to stimulate endothelium-independent vasodilatation)
  • Salbutamol 2 x 200 μg (Administered by spacer device to stimulate endothelium-dependent vasodilatation)

Forearm blood flow

  • Acetylcholine: 7.5μg/min, 15μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-dependent vasodilatation)
  • Sodium nitroprusside: 3μg/min, 10μg/min (Intra-arterial administration via brachial artery to stimulate endothelium-independent vasodilatation)
  • LNMMA: 2μmol/min, 4μmol/min (Intra-arterial administration via brachial artery to block basal nitric oxide production)
Other: Brief lifestyle/medical history questionnaire
Core Measurement
Other: Anthropometric measures
Core Measurement
Other: Blood pressure and arterial stiffness
Core Measurement
Other: Cardiac output and lung function
Core Measurement
Other: Heart rate variability
Core Measurement
Other: Blood sample & spot urine sample
Core Measurement
Other: 24 hour ambulatory blood pressure monitor
Detailed Measurement (Optional for participants).
Other: 24 hour urine collection
Detailed Measurement (Optional for participants).
Other: Echocardiograph: Left ventricular mass
Detailed Measurement (Optional for participants).
Other: Large artery structure: Carotid intima-media thickness
Detailed Measurement (Optional for participants).
Other: Small artery structure: Minimum forearm vascular resistance
Detailed Measurement (Optional for participants).
Other: Large artery endothelial function
Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
Other: Small artery endothelial function: Forearm blood flow
Detailed Measurement (Optional for participants).
Other: Dundee step test
Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
Other: Detailed haemodynamic response to submaximal exercise
Detailed Measurement (Optional for participants).
Other: Cardiopulmonary fitness: Maximum oxygen consumption
Detailed Measurement (Optional for participants).
Other: Haemodynamic response to mental stress
Detailed Measurement (Optional for participants).
Other: Small artery dilatory function: Forearm blood flow
Detailed Measurement (Optional for participants).
Hypertensive Patients (Cross-sectional)

No IMP to be administered, only challenge agents as part of the physiological assessments.

Large artery endothelial function:

Same challenge agents as healthy volunteer and hypertensive patient (Case-control) arms

Forearm blood flow Same challenge agents as healthy volunteer and hypertensive patient (Case-control) arms

Recruited from community-based cohort studies - CLEAREST and ACCT

Equal recruitment across the following parameters:

  • Age: 3 groups <30, 30-60, >60 years
  • Gender
  • BMI: 3 groups <25, 25-30, >30 Kg/m2
Other: Brief lifestyle/medical history questionnaire
Core Measurement
Other: Anthropometric measures
Core Measurement
Other: Blood pressure and arterial stiffness
Core Measurement
Other: Cardiac output and lung function
Core Measurement
Other: Heart rate variability
Core Measurement
Other: Blood sample & spot urine sample
Core Measurement
Other: 24 hour ambulatory blood pressure monitor
Detailed Measurement (Optional for participants).
Other: 24 hour urine collection
Detailed Measurement (Optional for participants).
Other: Echocardiograph: Left ventricular mass
Detailed Measurement (Optional for participants).
Other: Large artery structure: Carotid intima-media thickness
Detailed Measurement (Optional for participants).
Other: Small artery structure: Minimum forearm vascular resistance
Detailed Measurement (Optional for participants).
Other: Large artery endothelial function
Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
Other: Small artery endothelial function: Forearm blood flow
Detailed Measurement (Optional for participants).
Other: Dundee step test
Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
Other: Detailed haemodynamic response to submaximal exercise
Detailed Measurement (Optional for participants).
Other: Cardiopulmonary fitness: Maximum oxygen consumption
Detailed Measurement (Optional for participants).
Other: Haemodynamic response to mental stress
Detailed Measurement (Optional for participants).
Other: Small artery dilatory function: Forearm blood flow
Detailed Measurement (Optional for participants).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cardiac Output (Measured by the inert gas re-breathing technique L/Min)
Time Frame: 5 years
5 years
Peripheral vascular resistance (Calculated using Cardiac Output and Blood pressure data dynes/sec/cm^5 )
Time Frame: 5 years
5 years
Pulse wave velocity (Measured by ECG-gated applanation tonometry meters/sec)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cambridge University Hospitals NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Cambridge

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carmel McEniery, PhD, University of Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AWE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Brief lifestyle/medical history questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings