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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014791
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
Carmel McEniery, Cambridge University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Cardiovascular Diseases Vascular Diseases Hypertension Other: Brief lifestyle/medical history questionnaire Other: Anthropometric measures Other: Blood pressure and arterial stiffness Other: Cardiac output and lung function Other: Heart rate variability Other: Blood sample & spot urine sample Other: 24 hour ambulatory blood pressure monitor Other: 24 hour urine collection Other: Echocardiograph: Left ventricular mass Other: Large artery structure: Carotid intima-media thickness Other: Small artery structure: Minimum forearm vascular resistance Other: Large artery endothelial function Other: Small artery endothelial function: Forearm blood flow Other: Dundee step test Other: Detailed haemodynamic response to submaximal exercise Other: Cardiopulmonary fitness: Maximum oxygen consumption Other: Haemodynamic response to mental stress Other: Small artery dilatory function: Forearm blood flow

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Influence of Age, Weight and Ethnic Background on Blood Pressure: AWE Study
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).




Primary Outcome Measures :
  1. Cardiac Output (Measured by the inert gas re-breathing technique L/Min) [ Time Frame: 5 years ]
  2. Peripheral vascular resistance (Calculated using Cardiac Output and Blood pressure data dynes/sec/cm^5 ) [ Time Frame: 5 years ]
  3. Pulse wave velocity (Measured by ECG-gated applanation tonometry meters/sec) [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
During the study, the blood and urine samples will be stored by the research team at the department of Experimental Medicine and Immunotherapeutics, Division of Cardiovascular Medicine under the responsibility of the CI who will ensure the security and confidentiality of the stored material. These samples will not be accessible to any investigator outside the research team. A small aliquot of the participant's blood and urine sample will be stored at approximately -80 degrees Celsius for future analyses. All samples taken during this study will be made anonymous. Samples obtained during this study will be used for future ethically approved studies. Participants will be made aware of this in the participant information sheet prior to the process of written informed consent.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014791


Contacts
Layout table for location contacts
Contact: Saranya Palanisamy 01223 256621 saranya.palanisamy@addenbrookes.nhs.uk
Contact: Carmel McEniery, PhD 01223 217564 cmm41@medschl.cam.ac.uk

Locations
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United Kingdom
Vascular Research Clinic, Addenbrooke's Hospital Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Carmel McEniery, PhD       cmm41@medschl.cam.ac.uk   
Principal Investigator: Carmel McEniery, MPhD         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Investigators
Layout table for investigator information
Principal Investigator: Carmel McEniery, PhD University of Cambridge
Layout table for additonal information
Responsible Party: Carmel McEniery, Senior Research Associate, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03014791    
Other Study ID Numbers: AWE
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carmel McEniery, Cambridge University Hospitals NHS Foundation Trust:
Epidemiology
Ethnicity
Age
Weight
Hypertensive
Cardiac Output
Peripheral Vascular Resistance
Arterial Stiffness
Healthy Volunteers
Endothelial function
Arterial Structure
Left ventricular mass/function
Additional relevant MeSH terms:
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Cardiovascular Diseases
Vascular Diseases