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Sympathetic Activity and Cardiometabolic Complications

Association Between Enhanced Sympathetic Activity and Cardiometabolic Complications: a Cross-sectional Study on Predictive Power of 24-hour Urinary Metanephrines (SYMPACT)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04495231
Acronym
SYMPACT
Enrollment
1380
Registered
2020-07-31
Start date
2007-09-01
Completion date
2020-07-01
Last updated
2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catecholamine; Overproduction, Catecholamine; Secretion, Diabetes Mellitus, Type 2, Hypertension,Essential, Hypertensive Heart Disease, Hypertensive Kidney Disease, Metabolic Syndrome

Keywords

Normetanephrine, Metanephrine, Sympathetic Nervous System, Cardiovascular System, Cardiometabolic Complications, Catecholamine; Overproduction, Catecholamine; Secretion, Metabolic Syndrome, Hypertensive Heart Disease, Hypertensive Kidney Disease, Diabetes Mellitus, Type 2, Hypertension,Essential

Brief summary

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.

Detailed description

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. Excluding patients with PPGL, however, metanephrines can be more broadly considered as reliable markers of the whole sympathetic system activity; therefore, their levels may be hypothesized to be associated to a higher rate of concurrent cardiometabolic complications and, if so, could be useful for the stratification of cardiovascular risk.

Interventions

None listed

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Presence of left ventricular hypertrophyAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of the presence of left ventricular hypertrophy
Presence of chronic kidney diseaseAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of the presence of chronic kidney disease
Presence of type 2 diabetes mellitusAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of the presence of type 2 diabetes mellitus
Presence of metabolic syndromeAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of the presence of metabolic syndrome

Secondary

MeasureTime frameDescription
Urinary albumin/creatinine ratioAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of albumin/creatinine ratio values (mg/mmol)
Fasting glucoseAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of fasting glucose values (mg/dl)
Total cholesterolAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of total cholesterol values (mg/dl)
HDL cholesterolAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of HDL cholesterol values (mg/dl)
LDL cholesterolAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of LDL cholesterol values (mg/dl, as estimated by Friedewald formula)
Systolic blood pressure (SBP)At baselineThe value of urinary metanephrines will be evaluated as a possible predictor of systolic blood pressure values (mmHg)
Body Mass Index (BMI)At baselineThe value of urinary metanephrines will be evaluated as a possible predictor of BMI values (kg/m2)
Cardiovascular risk as estimated by Framingham Risk Score (FRS)At baselineThe value of urinary metanephrines will be evaluated as a possible predictor of cardiovascular risk as estimated by FRS; FRS is expressed as a percentage, with higher values indicating higher risk; patients in which the risk estimation is not applicable will be excluded from the analysis
Cardiovascular risk as estimated by Systematic COronary Risk Evaluation (SCORE)At baselineThe value of urinary metanephrines will be evaluated as a possible predictor of cardiovascular risk as estimated by SCORE; SCORE is expressed as a percentage, with higher values indicating higher risk; patients in which the risk estimation is not applicable will be excluded from the analysis
Cardiovascular risk as estimated by Progetto Cuore Score (english translation: Heart Project Score)At baselineThe value of urinary metanephrines will be evaluated as a possible predictor of cardiovascular risk as estimated by Progetto Cuore Score; Progetto Cuore Score is expressed as a percentage, with higher values indicating higher risk; patients in which the risk estimation is not applicable will be excluded from the analysis
TriglyceridesAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of triglycerides values (mg/dl)
Diastolic blood pressure (DBP)At baselineThe value of urinary metanephrines will be evaluated as a possible predictor of diastolic blood pressure values (mmHg)
Resting heart rateAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of resting heart rate (bpm)
eGFRAt baselineThe value of urinary metanephrines will be evaluated as a possible predictor of eGFR values (ml/min, as estimated by CKD-EPI formula)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026