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The Role of the Immune and Inflammatory Systems in Hypertension

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ClinicalTrials.gov Identifier: NCT04015635
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
European Research Council
Information provided by (Responsible Party):
Eleanor Murray, University of Glasgow

Brief Summary:
To define the cytokine and cellular immune signature of primary hypertension. Cross sectional clinical/laboratory study.

Condition or disease Intervention/treatment
Hypertension Inflammation Vascular Diseases Other: None involved

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.

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Study Type : Observational
Estimated Enrollment : 240 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 : April 1, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study group

120 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

120 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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Endo-PAT2000 "hyperaemia index" [ Time Frame: until total number recruited or end of study period (June 2021) ]

    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


  2. flow mediated dilatation (FMD) (percent) [ Time Frame: until total number recruited or end of study period (June 2021) ]
    as a measure of endothelial function

  3. carotid intimal media thickness (mm) [ Time Frame: until total number recruited or end of study period (June 2021) ]
    measure of vascular stiffness and central pressure

  4. assessed by SphygmoCor (meters/second) [ Time Frame: until total number recruited or end of study period (June 2021) ]
    measure of vascular stiffness and central pressure

  5. serum Creatinine (mMol/L) [ Time Frame: until total number recruited or end of study period (June 2021) ]
    measure of renal function

  6. "International Physical Activity Questionnaire" (score) [ Time Frame: until end of study period (June 2021) ]
    Questionnaire measures of physical activity. From hours of sedentary time, mild/moderate/vigorous activity over a week, it then calculates METs/week.

  7. Interheart Diet Questionnaire score [ Time Frame: until end of study period (June 2021) ]
    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)


Biospecimen Retention:   Samples With DNA
Blood for flow cytometry. Blood and urine for biomarker analysis. Blood for possible RNA analysis


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Otherwise fit and healthy individuals with hypertension who are treatment naive.
Criteria

Inclusion Criteria:

  • Age between 18-50 years
  • Cases: Office blood pressure ≥140 and ≥90
  • Controls: Office blood pressure <140 and <90 and age, sex and BMI matching to cases

Exclusion Criteria:

  • Age >50 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
  • 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>35,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015635


Locations
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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         
Sponsors and Collaborators
University of Glasgow
European Research Council
  Study Documents (Full-Text)

Documents provided by Eleanor Murray, University of Glasgow:

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Responsible Party: Eleanor Murray, Prinicipal Investigator; Doctor; Clinical Research Fellow, University of Glasgow
ClinicalTrials.gov Identifier: NCT04015635     History of Changes
Other Study ID Numbers: 300798-01
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eleanor Murray, University of Glasgow:
blood pressure
hypertension
inflammation
immune dysfunction
endothelial dysfunction

Additional relevant MeSH terms:
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Hypertension
Inflammation
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes