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| Name | Class |
|---|---|
| European Research Council | OTHER |
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To define the cytokine and cellular immune signature of primary hypertension. Cross sectional clinical/laboratory study.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | 80 with hypertension, defined on office BP readings and confirmed with ambulatory blood pressure monitoring. Clinical and laboratory assessment. NO intervention. |
| |
| Control | 80 WITHOUT hypertension, defined on office BP readings and confirmed with ambulatory blood pressure monitoring. Clinical and laboratory assessment. NO intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None involved | Other | NO intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | rolling analysis until total number recruited or end of study period (June 2021) |
| demographics: blood pressure | systolic and diastolic; office and ambulatory; in mmHG | 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 | rolling analysis until total number recruited or end of study period (June 2021) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Otherwise fit and healthy individuals with hypertension who are treatment naive.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleanor Murray, MBChB | Contact | 0141 232 7600 | cams-ins-inflammatension@glasgow.ac.uk | |
| Tomasz Guzik, Prof | Contact | tomasz.guzik@glasgow.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Facility | Recruiting | Glasgow | City of Glasgow | G51 4LB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36528682 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 | Apr 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007249 | Inflammation |
| D014652 | Vascular Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Blood for flow cytometry. Blood and urine for biomarker analysis. Blood for possible RNA analysis
| until total number recruited or end of study period (June 2021) |
| flow mediated dilatation (FMD) (percent) | as a measure of endothelial function | until total number recruited or end of study period (June 2021) |
| carotid intimal media thickness (mm) | measure of vascular stiffness and central pressure | until total number recruited or end of study period (June 2021) |
| assessed by SphygmoCor (meters/second) | measure of vascular stiffness and central pressure | until total number recruited or end of study period (June 2021) |
| serum Creatinine (mMol/L) | measure of renal function | 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. | 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) | until end of study period (June 2021) |