AWE: Influence of Age, Weight and Ethnic Background on Blood Pressure
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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).
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vascular Research Clinic, Addenbrooke's Hospital | Cambridge | Cambridgeshire | United Kingdom | CB2 0QQ |
Sponsors and Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- University of Cambridge
Investigators
- Principal Investigator: Carmel McEniery, PhD, University of Cambridge
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AWE