Cardiovascular DiseasesAWENCT03014791
Influence of Age, Weight and Ethnic Background on Blood Pressure
An observational study of Cardiovascular Diseases and Vascular Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Vascular Diseases, Hypertension
- What is being tested?
- Brief lifestyle/medical history questionnaire, Anthropometric measures and Blood pressure and arterial stiffness
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2017to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Male or Female, aged 18 or above
- Able to give informed consent and willing to participate
Who cannot join
- Pregnancy
- Current active malignancy
- Currently receiving dialysis
- Any illness with a life expectancy < 1 year
- Lack of written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Vascular Research Clinic, Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Carmel McEniery, PhD, cmm41@medschl.cam.ac.uk
Carmel McEniery, MPhD
About this study
Official title: 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.
- Conditions
- Cardiovascular Diseases, Vascular Diseases, Hypertension
- Being tested
- Brief lifestyle/medical history questionnaire, Anthropometric measures, Blood pressure and arterial stiffness, Cardiac output and lung function, Heart rate variability
- Keywords
- Epidemiology, Ethnicity, Age, Weight, Hypertensive, Cardiac Output, Peripheral Vascular Resistance, Arterial Stiffness, Healthy Volunteers, Endothelial function, Arterial Structure, Left ventricular mass/function
- Medical subject headings
- Cardiovascular Diseases, Vascular Diseases, Hypertension, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief lifestyle/medical history questionnaireOther
Core Measurement
Anthropometric measuresOther
Core Measurement
Blood pressure and arterial stiffnessOther
Core Measurement
Cardiac output and lung functionOther
Core Measurement
Heart rate variabilityOther
Core Measurement
Blood sample & spot urine sampleOther
Core Measurement
24 hour ambulatory blood pressure monitorOther
Detailed Measurement (Optional for participants).
24 hour urine collectionOther
Detailed Measurement (Optional for participants).
Echocardiograph: Left ventricular massOther
Detailed Measurement (Optional for participants).
Large artery structure: Carotid intima-media thicknessOther
Detailed Measurement (Optional for participants).
Small artery structure: Minimum forearm vascular resistanceOther
Detailed Measurement (Optional for participants).
Large artery endothelial functionOther
Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
Small artery endothelial function: Forearm blood flowOther
Detailed Measurement (Optional for participants).
Dundee step testOther
Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
Detailed haemodynamic response to submaximal exerciseOther
Detailed Measurement (Optional for participants).
Cardiopulmonary fitness: Maximum oxygen consumptionOther
Detailed Measurement (Optional for participants).
Haemodynamic response to mental stressOther
Detailed Measurement (Optional for participants).
Small artery dilatory function: Forearm blood flowOther
Detailed Measurement (Optional for participants).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 | |
| 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) Receives: 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 | |
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output (Measured by the inert gas re-breathing technique L/Min)
Measured: 5 years
Peripheral vascular resistance (Calculated using Cardiac Output and Blood pressure data dynes/sec/cm^5 )
Measured: 5 years
Pulse wave velocity (Measured by ECG-gated applanation tonometry meters/sec)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start21 Feb 2017
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Carmel McEniery, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Carmel McEniery, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014791
- Sponsor's protocol ID
- AWE
- Acronym
- AWE
- Status last verified
- Aug 2022
- First submitted
- 6 Jan 2017
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Age, Weight and Ethnic Background on Blood Pressure: AWE Study
- ClinicalTrials.gov ID
- NCT03014791
- Acronym / sponsor ID
- AWE / AWE
- Conditions
- Cardiovascular Diseases, Vascular Diseases, Hypertension
- Keywords
- Epidemiology, Ethnicity, Age, Weight, Hypertensive, Cardiac Output, Peripheral Vascular Resistance, Arterial Stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | 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 flowNo 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) |
| Hypertensive Patients (Case-control) | – | 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 flowNo 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) |
| Hypertensive Patients (Cross-sectional) | – | 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 flowNo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male or Female, aged 18 or above
- Able to give informed consent and willing to participate
Key exclusion criteria (5 listed)
- Pregnancy
- Current active malignancy
- Currently receiving dialysis
- Any illness with a life expectancy < 1 year
- Lack of written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief lifestyle/medical history questionnaireCore Measurement | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Anthropometric measuresCore Measurement | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Blood pressure and arterial stiffnessCore Measurement | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Cardiac output and lung functionCore Measurement | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Heart rate variabilityCore Measurement | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Blood sample & spot urine sampleCore Measurement | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| 24 hour ambulatory blood pressure monitorDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| 24 hour urine collectionDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Echocardiograph: Left ventricular massDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Large artery structure: Carotid intima-media thicknessDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Small artery structure: Minimum forearm vascular resistanceDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Large artery endothelial functionFlow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Small artery endothelial function: Forearm blood flowDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Dundee step testSystolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Detailed haemodynamic response to submaximal exerciseDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Cardiopulmonary fitness: Maximum oxygen consumptionDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Haemodynamic response to mental stressDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
| Small artery dilatory function: Forearm blood flowDetailed Measurement (Optional for participants). | Other | Healthy Volunteers, Hypertensive Patients (Case-control), Hypertensive Patients (Cross-sectional) |
Primary outcome
Cardiac Output (Measured by the inert gas re-breathing technique L/Min)
Time frame: 5 years
Peripheral vascular resistance (Calculated using Cardiac Output and Blood pressure data dynes/sec/cm^5 )
Time frame: 5 years
Pulse wave velocity (Measured by ECG-gated applanation tonometry meters/sec)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmel McEniery, PhD principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Vascular Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie Byrne (01223 349762, natalie.byrne@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (Measured by the inert gas re-breathing technique L/Min) (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.