A Study of the Roles of the Immune and Inflammatory Systems in Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- demographics: BMI
研究概览
简要总结
To define the cytokine and cellular immune signature of primary hypertension. Cross sectional clinical/laboratory study.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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;
- •diabetes/glucose intolerance (fasting glucose, HbA1; testing, glucose challenge where indicated);
- •Known albuminuria/microalbuminuria;
- •GFR<60mL/min/1.73m
- •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
结局指标
主要结局
demographics: BMI
时间窗: 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
cellular immune signature of primary hypertension: flow cytometry quantification of peripheral blood monocyte subtypes
时间窗: 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
时间窗: rolling analysis until total number recruited or end of study period (June 2021)
systolic and diastolic; office and ambulatory; in mmHG
次要结局
- carotid intimal media thickness (mm)(until total number recruited or end of study period (June 2021))
- assessed by SphygmoCor (meters/second)(until total number recruited or end of study period (June 2021))
- flow mediated dilatation (FMD) (percent)(until total number recruited or end of study period (June 2021))
- Interheart Diet Questionnaire score(until end of study period (June 2021))
- Endo-PAT2000 "hyperaemia index"(until total number recruited or end of study period (June 2021))
- serum Creatinine (mMol/L)(until total number recruited or end of study period (June 2021))
- "International Physical Activity Questionnaire" (score)(until end of study period (June 2021))
研究者
TOMASZ GUZIK
Prinicipal Investigator; Professor
University of Glasgow