Condition or disease | Intervention/treatment |
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Hypertension Inflammation Vascular Diseases | Other: None involved |
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 :
Study Type : | Observational |
Estimated Enrollment : | 160 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Study of the Roles of the Immune and Inflammatory Systems in Hypertension |
Actual Study Start Date : | May 7, 2019 |
Estimated Primary Completion Date : | September 1, 2021 |
Estimated Study Completion Date : | September 1, 2021 |
Group/Cohort | Intervention/treatment |
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Study group
80 with hypertension, defined on office BP readings and confirmed with ambulatory blood pressure monitoring. Clinical and laboratory assessment. NO intervention. |
Other: None involved
NO intervention
|
Control
80 WITHOUT hypertension, defined on office BP readings and confirmed with ambulatory blood pressure monitoring. Clinical and laboratory assessment. NO intervention. |
Other: None involved
NO intervention
|
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
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eleanor Murray, MBChB | 0141 232 7600 | cams-ins-inflammatension@glasgow.ac.uk | |
Contact: Tomasz Guzik, Prof | tomasz.guzik@glasgow.ac.uk |
United Kingdom | |
Clinical Research Facility | Recruiting |
Glasgow, City Of Glasgow, United Kingdom, G51 4LB | |
Contact: tomasz guzik 0141 3307590 cams-ins-inflammatension@glasgow.ac.uk | |
Contact: Joanne Flynn 0141 232 7600 joanne.flynn@ggc.scot.nhs.uk | |
Principal Investigator: eleanor c murray |
Tracking Information | |||||||||
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First Submitted Date | April 30, 2019 | ||||||||
First Posted Date | July 11, 2019 | ||||||||
Last Update Posted Date | May 14, 2021 | ||||||||
Actual Study Start Date | May 7, 2019 | ||||||||
Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | The Role of the Immune and Inflammatory Systems in Hypertension | ||||||||
Official Title | A Study of the Roles of the Immune and Inflammatory Systems in Hypertension | ||||||||
Brief Summary | 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 :
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples With DNA Description:
Blood for flow cytometry. Blood and urine for biomarker analysis. Blood for possible RNA analysis
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Sampling Method | Non-Probability Sample | ||||||||
Study Population | Otherwise fit and healthy individuals with hypertension who are treatment naive. | ||||||||
Condition |
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Intervention | Other: None involved
NO intervention
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
160 | ||||||||
Original Estimated Enrollment |
240 | ||||||||
Estimated Study Completion Date | September 1, 2021 | ||||||||
Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 55 Years (Adult) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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Listed Location Countries | United Kingdom | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04015635 | ||||||||
Other Study ID Numbers | 300798-01 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | TOMASZ GUZIK, University of Glasgow | ||||||||
Study Sponsor | University of Glasgow | ||||||||
Collaborators | European Research Council | ||||||||
Investigators | Not Provided | ||||||||
PRS Account | University of Glasgow | ||||||||
Verification Date | May 2021 |