Association Between Enhanced Sympathetic Activity and Cardiometabolic Complications: a Cross-sectional Study on Predictive Power of 24-hour Urinary Metanephrines (SYMPACT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,380
- 试验地点
- 1
- 主要终点
- Presence of type 2 diabetes mellitus
研究概览
简要总结
Recent studies on catecholamine physiology have shown a direct correlation with arterial hypertension, overcoming the exclusive role in the diagnosis and follow-up of chromaffin tumors.
Nevertheless, in literature, few studies explore and reveal the utility of testing metanephrines for the evaluation of sympathetic activity and its associated cardiometabolic complications in patients with essential hypertension.
详细描述
Catecholamines (noradrenaline, adrenaline and dopamine) are adaptive and maladaptive stress hormones.
In the classic "fight or flight" mechanism, they activate behavioral and physiological processes that facilitate the overcoming of stress; for instance, challenged by a physical stressor, an organism responds to the threat either fighting and prevailing or accepting defeat and fleeing in avoidance.
In the pathological context, an excessive catecholamine secretion is typical of the chromaffin tissue tumors, determining a clinical picture characterized by blood pressure elevation, tachycardia, anxiety, pallor, sweating and headache.
COMT enzyme catalyzes the O-methylation of the 3-hydroxyl group of catecholamines. The O-methylated derivatives of noradrenaline, adrenaline and dopamine are normetanephrine, metanephrine and 3-methoxytyramine, respectively. The term "metanephrines" is generally used to collectively refer to the first two compounds.
Compared to catecholamines, metanephrines are characterized by longer half-life and more stable levels over time. Their superior accuracy for the diagnosis and follow-up of pheochromocytoma and paraganglioma (PPGL) has been widely proved.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Measurement of 24h urinary metanephrines at the laboratory of "City of Health and Science" hospital in Turin between 2007 and 2015
- •Availability of contextual clinical patient data as collected in prospective registries of Piedmont region
排除标准
- •Diagnosis of pheochromocytoma or paraganglioma (at the time of urinary metanephrines collection or within the following 5 years)
- •Diagnosis of other forms of secondary hypertension
- •Previous cardiovascular or cerebrovascular event
- •Chronic heart failure
- •eGFR < 50 ml/min (according to CKD-EPI)
- •Liver cirrhosis
- •Acute conditions and/or hospitalization in ICU (at the time of urinary metanephrines collection)
- •Assumption of acetaminophen during the day before the 24-hour urine collection
- •Therapy with labetalol
- •Therapy with sotalol
- •Therapy with alpha-methyldopa
- •Therapy with MAO inhibitors
- •Therapy with tricyclic antidepressants
- •Therapy with buspirone
- •Therapy with phenoxybenzamine
- •Therapy with sulfasalazine
- •Therapy with L-Dopa
- •Therapy with sympathomimetic drugs or other vasopressors
- •Alcohol abuse
- •Cocaine abuse
结局指标
主要结局
Presence of type 2 diabetes mellitus
时间窗: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of type 2 diabetes mellitus
Presence of metabolic syndrome
时间窗: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of metabolic syndrome
Presence of chronic kidney disease
时间窗: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of chronic kidney disease
Presence of left ventricular hypertrophy
时间窗: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of the presence of left ventricular hypertrophy
次要结局
- Body Mass Index (BMI)(At baseline)
- Urinary albumin/creatinine ratio(At baseline)
- Total cholesterol(At baseline)
- LDL cholesterol(At baseline)
- eGFR(At baseline)
- Fasting glucose(At baseline)
- Systolic blood pressure (SBP)(At baseline)
- Triglycerides(At baseline)
- Cardiovascular risk as estimated by Progetto Cuore Score (english translation: "Heart Project Score")(At baseline)
- Diastolic blood pressure (DBP)(At baseline)
- Resting heart rate(At baseline)
- HDL cholesterol(At baseline)
- Cardiovascular risk as estimated by Framingham Risk Score (FRS)(At baseline)
- Cardiovascular risk as estimated by Systematic COronary Risk Evaluation (SCORE)(At baseline)
研究者
Mauro Maccario
Medical Doctor, Professor
University of Turin, Italy