Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Cambridge | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | No IMP to be administered, only challenge agents as part of the physiological assessments. Large artery endothelial function:
Forearm blood flow
|
| |
| Hypertensive Patients (Case-control) | No IMP to be administered, only challenge agents as part of the physiological assessments. Large artery endothelial function:
Forearm blood flow
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief lifestyle/medical history questionnaire | Other | Core Measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Byrne | Contact | 01223 349762 | natalie.byrne@addenbrookes.nhs.uk | |
| Carmel McEniery, PhD | Contact | 01223 217564 | cmm41@medschl.cam.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Carmel McEniery, PhD | University of Cambridge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Research Clinic, Addenbrooke's Hospital | Recruiting | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
| 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:
|
|
| Anthropometric measures | Other | Core Measurement |
|
| Blood pressure and arterial stiffness | Other | Core Measurement |
|
| Cardiac output and lung function | Other | Core Measurement |
|
| Heart rate variability | Other | Core Measurement |
|
| Blood sample & spot urine sample | Other | Core Measurement |
|
| 24 hour ambulatory blood pressure monitor | Other | Detailed Measurement (Optional for participants). |
|
| 24 hour urine collection | Other | Detailed Measurement (Optional for participants). |
|
| Echocardiograph: Left ventricular mass | Other | Detailed Measurement (Optional for participants). |
|
| Large artery structure: Carotid intima-media thickness | Other | Detailed Measurement (Optional for participants). |
|
| Small artery structure: Minimum forearm vascular resistance | Other | Detailed Measurement (Optional for participants). |
|
| Large artery endothelial function | Other | Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants). |
|
| Small artery endothelial function: Forearm blood flow | Other | Detailed Measurement (Optional for participants). |
|
| Dundee step test | Other | Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants). |
|
| Detailed haemodynamic response to submaximal exercise | Other | Detailed Measurement (Optional for participants). |
|
| Cardiopulmonary fitness: Maximum oxygen consumption | Other | Detailed Measurement (Optional for participants). |
|
| Haemodynamic response to mental stress | Other | Detailed Measurement (Optional for participants). |
|
| Small artery dilatory function: Forearm blood flow | Other | Detailed Measurement (Optional for participants). |
|
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D006973 | Hypertension |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| D059289 | Vascular Stiffness |
| D002302 | Cardiac Output |
| D014691 | Ventilation |
| D001800 | Blood Specimen Collection |
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004780 | Environment, Controlled |
| D004777 | Environment |
| D004778 | Environment and Public Health |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided