Influence of Age, Weight and Ethnic Background on Blood Pressure
NCT ID: NCT03014791
Last Updated: 2022-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
500 participants
OBSERVATIONAL
2017-02-21
2024-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Young Adult Hypertension Self-Management Clinical Trial
NCT03158051
Evaluating the Relationship Between Stress, Ethnicity, and Blood Pressure
NCT00783497
Home Blood Pressure Intervention in the Community Trial
NCT05858944
Intervention Study to Control High Blood Pressure for Korean American
NCT00473681
Impact of Computerized Reminders on Blood Pressure Documentation and Control
NCT01640704
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
Brief lifestyle/medical history questionnaire
Core Measurement
Anthropometric measures
Core Measurement
Blood pressure and arterial stiffness
Core Measurement
Cardiac output and lung function
Core Measurement
Heart rate variability
Core Measurement
Blood sample & spot urine sample
Core Measurement
24 hour ambulatory blood pressure monitor
Detailed Measurement (Optional for participants).
24 hour urine collection
Detailed Measurement (Optional for participants).
Echocardiograph: Left ventricular mass
Detailed Measurement (Optional for participants).
Large artery structure: Carotid intima-media thickness
Detailed Measurement (Optional for participants).
Small artery structure: Minimum forearm vascular resistance
Detailed Measurement (Optional for participants).
Large artery endothelial function
Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
Small artery endothelial function: Forearm blood flow
Detailed Measurement (Optional for participants).
Dundee step test
Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
Detailed haemodynamic response to submaximal exercise
Detailed Measurement (Optional for participants).
Cardiopulmonary fitness: Maximum oxygen consumption
Detailed Measurement (Optional for participants).
Haemodynamic response to mental stress
Detailed Measurement (Optional for participants).
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)
Brief lifestyle/medical history questionnaire
Core Measurement
Anthropometric measures
Core Measurement
Blood pressure and arterial stiffness
Core Measurement
Cardiac output and lung function
Core Measurement
Heart rate variability
Core Measurement
Blood sample & spot urine sample
Core Measurement
24 hour ambulatory blood pressure monitor
Detailed Measurement (Optional for participants).
24 hour urine collection
Detailed Measurement (Optional for participants).
Echocardiograph: Left ventricular mass
Detailed Measurement (Optional for participants).
Large artery structure: Carotid intima-media thickness
Detailed Measurement (Optional for participants).
Small artery structure: Minimum forearm vascular resistance
Detailed Measurement (Optional for participants).
Large artery endothelial function
Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
Small artery endothelial function: Forearm blood flow
Detailed Measurement (Optional for participants).
Dundee step test
Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
Detailed haemodynamic response to submaximal exercise
Detailed Measurement (Optional for participants).
Cardiopulmonary fitness: Maximum oxygen consumption
Detailed Measurement (Optional for participants).
Haemodynamic response to mental stress
Detailed Measurement (Optional for participants).
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
Brief lifestyle/medical history questionnaire
Core Measurement
Anthropometric measures
Core Measurement
Blood pressure and arterial stiffness
Core Measurement
Cardiac output and lung function
Core Measurement
Heart rate variability
Core Measurement
Blood sample & spot urine sample
Core Measurement
24 hour ambulatory blood pressure monitor
Detailed Measurement (Optional for participants).
24 hour urine collection
Detailed Measurement (Optional for participants).
Echocardiograph: Left ventricular mass
Detailed Measurement (Optional for participants).
Large artery structure: Carotid intima-media thickness
Detailed Measurement (Optional for participants).
Small artery structure: Minimum forearm vascular resistance
Detailed Measurement (Optional for participants).
Large artery endothelial function
Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
Small artery endothelial function: Forearm blood flow
Detailed Measurement (Optional for participants).
Dundee step test
Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
Detailed haemodynamic response to submaximal exercise
Detailed Measurement (Optional for participants).
Cardiopulmonary fitness: Maximum oxygen consumption
Detailed Measurement (Optional for participants).
Haemodynamic response to mental stress
Detailed Measurement (Optional for participants).
Small artery dilatory function: Forearm blood flow
Detailed Measurement (Optional for participants).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brief lifestyle/medical history questionnaire
Core Measurement
Anthropometric measures
Core Measurement
Blood pressure and arterial stiffness
Core Measurement
Cardiac output and lung function
Core Measurement
Heart rate variability
Core Measurement
Blood sample & spot urine sample
Core Measurement
24 hour ambulatory blood pressure monitor
Detailed Measurement (Optional for participants).
24 hour urine collection
Detailed Measurement (Optional for participants).
Echocardiograph: Left ventricular mass
Detailed Measurement (Optional for participants).
Large artery structure: Carotid intima-media thickness
Detailed Measurement (Optional for participants).
Small artery structure: Minimum forearm vascular resistance
Detailed Measurement (Optional for participants).
Large artery endothelial function
Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
Small artery endothelial function: Forearm blood flow
Detailed Measurement (Optional for participants).
Dundee step test
Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
Detailed haemodynamic response to submaximal exercise
Detailed Measurement (Optional for participants).
Cardiopulmonary fitness: Maximum oxygen consumption
Detailed Measurement (Optional for participants).
Haemodynamic response to mental stress
Detailed Measurement (Optional for participants).
Small artery dilatory function: Forearm blood flow
Detailed Measurement (Optional for participants).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to give informed consent and willing to participate
Exclusion Criteria
* Current active malignancy
* Currently receiving dialysis
* Any illness with a life expectancy \< 1 year
* Lack of written informed consent
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Cambridge
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carmel McEniery
Senior Research Associate
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carmel McEniery, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vascular Research Clinic, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AWE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.