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

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NHS Foundation Trust

Status

Enrolling

Conditions

Hypertension
Cardiovascular Diseases
Vascular Diseases

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT03014791
AWE

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Healthy Volunteers
Description:
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)
Treatment:
Other: Cardiopulmonary fitness: Maximum oxygen consumption
Other: Brief lifestyle/medical history questionnaire
Other: Cardiac output and lung function
Other: Small artery endothelial function: Forearm blood flow
Other: 24 hour ambulatory blood pressure monitor
Other: Blood pressure and arterial stiffness
Other: Large artery endothelial function
Other: Dundee step test
Other: Echocardiograph: Left ventricular mass
Other: Large artery structure: Carotid intima-media thickness
Other: Detailed haemodynamic response to submaximal exercise
Other: Blood sample & spot urine sample
Other: Anthropometric measures
Other: 24 hour urine collection
Other: Heart rate variability
Other: Small artery dilatory function: Forearm blood flow
Other: Haemodynamic response to mental stress
Other: Small artery structure: Minimum forearm vascular resistance
Hypertensive Patients (Case-control)
Description:
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)
Treatment:
Other: Cardiopulmonary fitness: Maximum oxygen consumption
Other: Brief lifestyle/medical history questionnaire
Other: Cardiac output and lung function
Other: Small artery endothelial function: Forearm blood flow
Other: 24 hour ambulatory blood pressure monitor
Other: Blood pressure and arterial stiffness
Other: Large artery endothelial function
Other: Dundee step test
Other: Echocardiograph: Left ventricular mass
Other: Large artery structure: Carotid intima-media thickness
Other: Detailed haemodynamic response to submaximal exercise
Other: Blood sample & spot urine sample
Other: Anthropometric measures
Other: 24 hour urine collection
Other: Heart rate variability
Other: Small artery dilatory function: Forearm blood flow
Other: Haemodynamic response to mental stress
Other: Small artery structure: Minimum forearm vascular resistance
Hypertensive Patients (Cross-sectional)
Description:
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
Treatment:
Other: Cardiopulmonary fitness: Maximum oxygen consumption
Other: Brief lifestyle/medical history questionnaire
Other: Cardiac output and lung function
Other: Small artery endothelial function: Forearm blood flow
Other: 24 hour ambulatory blood pressure monitor
Other: Blood pressure and arterial stiffness
Other: Large artery endothelial function
Other: Dundee step test
Other: Echocardiograph: Left ventricular mass
Other: Large artery structure: Carotid intima-media thickness
Other: Detailed haemodynamic response to submaximal exercise
Other: Blood sample & spot urine sample
Other: Anthropometric measures
Other: 24 hour urine collection
Other: Heart rate variability
Other: Small artery dilatory function: Forearm blood flow
Other: Haemodynamic response to mental stress
Other: Small artery structure: Minimum forearm vascular resistance

Trial contacts and locations

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Central trial contact

Natalie Byrne; Carmel McEniery, PhD

Data sourced from clinicaltrials.gov

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