Clinical trial NCT04015635: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Inflammation
Vascular Diseases
Keywords: blood pressure
hypertension
inflammation
immune dysfunction
endothelial dysfunction
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: European Research Council
First posted: 2019-07-11
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Otherwise fit and healthy individuals with hypertension who are treatment naive.

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 :

* 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: cellular immune signature of primary hypertension: flow cytometry quantification of peripheral blood monocyte subtypes
timeFrame: rolling analysis until total number recruited or end of study period (June 2021)
measure: demographics: blood pressure
timeFrame: rolling analysis until total number recruited or end of study period (June 2021)
measure: demographics: BMI
timeFrame: rolling analysis until total number recruited or end of study period (June 2021)
Secondary outcomes:
measure: Endo-PAT2000 "hyperaemia index"
timeFrame: until total number recruited or end of study period (June 2021)
measure: flow mediated dilatation (FMD) (percent)
timeFrame: until total number recruited or end of study period (June 2021)
measure: carotid intimal media thickness (mm)
timeFrame: until total number recruited or end of study period (June 2021)
measure: assessed by SphygmoCor (meters/second)
timeFrame: until total number recruited or end of study period (June 2021)
measure: serum Creatinine (mMol/L)
timeFrame: until total number recruited or end of study period (June 2021)
measure: "International Physical Activity Questionnaire" (score)
timeFrame: until end of study period (June 2021)
measure: Interheart Diet Questionnaire score
timeFrame: until end of study period (June 2021)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Clinical Research Facility
state: City Of Glasgow
Study officials:
References: