HypertensionNCT04015635
The Role of the Immune and Inflammatory Systems in Hypertension
An observational study of Hypertension and Inflammation, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
To define the cytokine and cellular immune signature of primary hypertension. Cross sectional clinical/laboratory study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Inflammation, Vascular Diseases
- What is being tested?
- None involved
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2019to 1 Sep 2021
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Otherwise fit and healthy individuals with hypertension who are treatment naive.
Who may be able to join
- Age between 18-55 years
- Cases: Office blood pressure ≥140 and ≥90
- Controls: Office blood pressure <140 and <90 and age, sex and BMI matching to cases
Who cannot join
- Age >55 years old;
- Secondary hypertension (including e.g. adrenal tumours, pheochromocytoma, renal artery stenosis; thyroid disease)
- Acute inflammatory disorders incl. flu, rhinitis, sinusitis etc. within 3 weeks;
- hospitalization within the past 3 months;
- Life expectancy of < 3 years;
- History of alcohol/substance abuse
Show all 17Show fewer
- Inflammatory conditions e.g. Allergic disorders; chronic infections, COPD, tuberculosis; hepatitis B or C; pneumonitis, bronchiectasis; pericardial or pleural effusion, ascites; liver disease;
- Chronic inflammatory/autoimmune conditions such (e.g. SLE, rheumatoid arthritis, ulcerative colitis/Crohn's disease; non-basal cell malignancy or myelo- or lymphoproliferative disease within the past 5 years; known HIV+; Immunizations (3 months); pulmonary hypertension;
- Pregnancy, nursing;
- History of symptomatic coronary artery disease (events) or heart failure;
- BMI>40,
- diabetes/glucose intolerance (fasting glucose, HbA1; testing, glucose challenge where indicated);
- Known albuminuria/microalbuminuria;
- GFR<60mL/min/1.73m2.
- Any chronic concurrent treatment: Use of systemic or local steroids/immunosuppressive agents (within 6 months) of the inclusion; Current (within past 3 months) use of anti-hypertensive medication;
- Major depressive illness or other psychiatric conditions.
- Participants who decline participation in the study or who are unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Tomasz Guzik, Prof contact
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Research Facility
Glasgow, City of Glasgow, G51 4LB
tomasz guzik, 0141 3307590, cams-ins-inflammatension@glasgow.ac.uk
Joanne Flynn, 0141 232 7600, joanne.flynn@ggc.scot.nhs.uk
About this study
Official title: A Study of the Roles of the Immune and Inflammatory Systems in Hypertension
To define the cytokine and cellular immune signature of primary hypertension. Cross sectional clinical/laboratory study.
Read the detailed description
Experimental data show the presence of immune and inflammatory systems dysregulation in hypertension. Understanding of the inflammatory and immune nature of hypertension is currently based on studies in rodent models of hypertension, but is supported by human epidemiological and genome wide association studies (GWAS) studies. It is now essential to identify key checkpoints and inflammatory mechanism(s) involved in human hypertension in comprehensive and sufficiently powered studies, which will then be able to guide subsequent in-depth hypothesis-driven mechanistic studies. This approach may provide the basis for future randomized clinical trials (RCTs).
To define the relationships and predictive value of the immune signature of hypertension and clinical phenotypes of hypertension :
- Predictive value of immune signature for blood pressure parameters measured by ambulatory blood pressure measurements (ABPM)
- Predictive value of immune signature for endothelial function assessed by Endo-PAT2000 and flow mediated dilatation (FMD) both complementary non-invasive techniques.
- Predictive value of immune signature for vascular stiffness and central pressure assessed by SphygmoCor
- Predictive value of immune signature for renal function parameters
- Predictive value of immune signature for cognitive function. To define genetic determinants of immune signature of hypertension.
- Conditions
- Hypertension, Inflammation, Vascular Diseases
- Being tested
- None involved
- Keywords
- blood pressure, hypertension, inflammation, immune dysfunction, endothelial dysfunction
- Medical subject headings
- Hypertension, Inflammation, Vascular Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None involvedOther
NO intervention
| Study group | Role | What they receive |
|---|---|---|
| Study group | 80 with hypertension, defined on office BP readings and confirmed with ambulatory blood pressure monitoring.
Clinical and laboratory assessment. NO intervention. Receives: Other: None involved | |
| Control | 80 WITHOUT hypertension, defined on office BP readings and confirmed with ambulatory blood pressure monitoring.
Clinical and laboratory assessment. NO intervention. Receives: Other: None involved |
What is being measured
The primary outcome is the main question the study is designed to answer.
cellular immune signature of primary hypertension: flow cytometry quantification of peripheral blood monocyte subtypes
measuring expression of B cells markers, T cell markers, and DC cell markers
Measured: rolling analysis until total number recruited or end of study period (June 2021)
demographics: blood pressure
systolic and diastolic; office and ambulatory; in mmHG
Measured: rolling analysis until total number recruited or end of study period (June 2021)
demographics: BMI
in kg/m^2; calculated from height in meters and weight in kg
Measured: rolling analysis until total number recruited or end of study period (June 2021)
Secondary outcomes (7)
Endo-PAT2000 "hyperaemia index"
As a measure of endothelial function: measuring Peripheral Arterial Tone (PAT) signal changes to a reactive hyperemia challenge. The PAT signal is a measure of the digital pulsatile volume. The expected response is of a post occlusion increase of the PAT signal amplitude. PAT score is provided automatically by the system's software and is basically the ratio between the post- to pre- occlusion average signal size, corrected for systemic changes and baseline level.
changes
Measured: until total number recruited or end of study period (June 2021)
flow mediated dilatation (FMD) (percent)
as a measure of endothelial function
Measured: until total number recruited or end of study period (June 2021)
carotid intimal media thickness (mm)
measure of vascular stiffness and central pressure
Measured: until total number recruited or end of study period (June 2021)
assessed by SphygmoCor (meters/second)
measure of vascular stiffness and central pressure
Measured: until total number recruited or end of study period (June 2021)
serum Creatinine (mMol/L)
measure of renal function
Measured: until total number recruited or end of study period (June 2021)
"International Physical Activity Questionnaire" (score)
Questionnaire measures of physical activity. From hours of sedentary time, mild/moderate/vigorous activity over a week, it then calculates METs/week.
Measured: until end of study period (June 2021)
Interheart Diet Questionnaire score
Questionnaire measures of health and activity. Based on known risk factors ie smoking diabetes, family history, dietary factors. Used as a validated measure of cardiovascular risk; score from 0 (minimal risk) to 48 (high risk)
Measured: until end of study period (June 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start7 May 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council
- Responsible party
- Principal investigator, TOMASZ GUZIK, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015635
- Sponsor's protocol ID
- 300798-01
- Status last verified
- May 2021
- First submitted
- 30 Apr 2019
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Murray EC, Delles C, Orzechowski P, Renc P, Sitek A, Wagenaar J, Guzik TJ. Vascular phenotypes in early hypertension. J Hum Hypertens. 2023 Oct;37(10):898-906. doi: 10.1038/s41371-022-00794-7. Epub 2022 Dec 17.
PubMed 36528682
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Roles of the Immune and Inflammatory Systems in Hypertension
- ClinicalTrials.gov ID
- NCT04015635
- Acronym / sponsor ID
- 300798-01
- Conditions
- Hypertension, Inflammation, Vascular Diseases
- Keywords
- blood pressure, hypertension, inflammation, immune dysfunction, endothelial dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- European Research Council
- Study start
- 7 May 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 11 Jul 2019 (actual)
- 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.
To define the cytokine and cellular immune signature of primary hypertension. Cross sectional clinical/laboratory study.
Detailed description
Experimental data show the presence of immune and inflammatory systems dysregulation in hypertension. Understanding of the inflammatory and immune nature of hypertension is currently based on studies in rodent models of hypertension, but is supported by human epidemiological and genome wide association studies (GWAS) studies. It is now essential to identify key checkpoints and inflammatory mechanism(s) involved in human hypertension in comprehensive and sufficiently powered studies, which will then be able to guide subsequent in-depth hypothesis-driven mechanistic studies. This approach may provide the basis for future randomized clinical trials (RCTs).
To define the relationships and predictive value of the immune signature of hypertension and clinical phenotypes of hypertension :
- Predictive value of immune signature for blood pressure parameters measured by ambulatory blood pressure measurements (ABPM)
- Predictive value of immune signature for endothelial function assessed by Endo-PAT2000 and flow mediated dilatation (FMD) both complementary non-invasive techniques.
- Predictive value of immune signature for vascular stiffness and central pressure assessed by SphygmoCor
- Predictive value of immune signature for renal function parameters
- Predictive value of immune signature for cognitive function. To define genetic determinants of immune signature of hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: None involved80 with hypertension, defined on office BP readings and confirmed with ambulatory blood pressure monitoring. Clinical and laboratory assessment. NO intervention. |
| Control | – | Other: None involved80 WITHOUT hypertension, defined on office BP readings and confirmed with ambulatory blood pressure monitoring. Clinical and laboratory assessment. NO intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Otherwise fit and healthy individuals with hypertension who are treatment naive.
Key inclusion criteria (3 listed)
- Age between 18-55 years
- Cases: Office blood pressure ≥140 and ≥90
- Controls: Office blood pressure <140 and <90 and age, sex and BMI matching to cases
Key exclusion criteria (17 listed)
- Age >55 years old;
- Secondary hypertension (including e.g. adrenal tumours, pheochromocytoma, renal artery stenosis; thyroid disease)
- Acute inflammatory disorders incl. flu, rhinitis, sinusitis etc. within 3 weeks;
- hospitalization within the past 3 months;
- Life expectancy of < 3 years;
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 |
|---|---|---|
| None involvedNO intervention | Other | Control, Study group |
Primary outcome
cellular immune signature of primary hypertension: flow cytometry quantification of peripheral blood monocyte subtypes
Time frame: rolling analysis until total number recruited or end of study period (June 2021)
measuring expression of B cells markers, T cell markers, and DC cell markers
demographics: blood pressure
Time frame: rolling analysis until total number recruited or end of study period (June 2021)
systolic and diastolic; office and ambulatory; in mmHG
demographics: BMI
Time frame: rolling analysis until total number recruited or end of study period (June 2021)
in kg/m^2; calculated from height in meters and weight in kg
7 secondary outcomes
Endo-PAT2000 "hyperaemia index"
Time frame: until total number recruited or end of study period (June 2021)
flow mediated dilatation (FMD) (percent)
Time frame: until total number recruited or end of study period (June 2021)
carotid intimal media thickness (mm)
Time frame: until total number recruited or end of study period (June 2021)
assessed by SphygmoCor (meters/second)
Time frame: until total number recruited or end of study period (June 2021)
serum Creatinine (mMol/L)
Time frame: until total number recruited or end of study period (June 2021)
"International Physical Activity Questionnaire" (score)
Time frame: until end of study period (June 2021)
Interheart Diet Questionnaire score
Time frame: until end of study period (June 2021)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Derived from this study: PubMed 36528682Murray EC, Delles C, Orzechowski P, Renc P, Sitek A, Wagenaar J, Guzik TJ. Vascular phenotypes in early hypertension. J Hum Hypertens. 2023 Oct;37(10):898-906. doi: 10.1038/s41371-022-00794-7. Epub 2022 Dec 17.
- Individual participant dataSharing planned: Undecided
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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.
Tomasz Guzik, Prof contact
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 Hypertension and Inflammation, run by University of Glasgow 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 3 inclusion and 17 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 14 May 2021. 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 Eleanor Murray, MBChB (0141 232 7600, cams-ins-inflammatension@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cellular immune signature of primary hypertension: flow cytometry quantification of peripheral blood monocyte subtypes (time frame: rolling analysis until total number recruited or end of study period (June 2021)). 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?
On the ClinicalTrials.gov record for NCT04015635, which also lists 1 linked publication.
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 14 May 2021.