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Sympathetic Activity and Cardiometabolic Complications (SYMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495231
Recruitment Status : Completed
First Posted : July 31, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Mauro Maccario, University of Turin, Italy

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.


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

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.

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Study Type : Observational
Actual Enrollment : 1380 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Association Between Enhanced Sympathetic Activity and Cardiometabolic Complications: a Cross-sectional Study on Predictive Power of 24-hour Urinary Metanephrines (SYMPACT)
Actual Study Start Date : September 1, 2007
Actual Primary Completion Date : July 1, 2015
Actual Study Completion Date : July 1, 2020





Primary Outcome Measures :
  1. Presence of left ventricular hypertrophy [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of the presence of left ventricular hypertrophy

  2. Presence of chronic kidney disease [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of the presence of chronic kidney disease

  3. Presence of type 2 diabetes mellitus [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of the presence of type 2 diabetes mellitus

  4. Presence of metabolic syndrome [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of the presence of metabolic syndrome


Secondary Outcome Measures :
  1. Systolic blood pressure (SBP) [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of systolic blood pressure values (mmHg)

  2. Diastolic blood pressure (DBP) [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of diastolic blood pressure values (mmHg)

  3. Resting heart rate [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of resting heart rate (bpm)

  4. eGFR [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of eGFR values (ml/min, as estimated by CKD-EPI formula)

  5. Urinary albumin/creatinine ratio [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of albumin/creatinine ratio values (mg/mmol)

  6. Fasting glucose [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of fasting glucose values (mg/dl)

  7. Total cholesterol [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of total cholesterol values (mg/dl)

  8. HDL cholesterol [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of HDL cholesterol values (mg/dl)

  9. LDL cholesterol [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of LDL cholesterol values (mg/dl, as estimated by Friedewald formula)

  10. Triglycerides [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of triglycerides values (mg/dl)

  11. Body Mass Index (BMI) [ Time Frame: At baseline ]
    The value of urinary metanephrines will be evaluated as a possible predictor of BMI values (kg/m2)

  12. Cardiovascular risk as estimated by Framingham Risk Score (FRS) [ Time Frame: At baseline ]
    The 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

  13. Cardiovascular risk as estimated by Systematic COronary Risk Evaluation (SCORE) [ Time Frame: At baseline ]
    The 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

  14. Cardiovascular risk as estimated by Progetto Cuore Score (english translation: "Heart Project Score") [ Time Frame: At baseline ]
    The 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who performed a 24h urinary metanephrines assay at the laboratory of "City of Health and Science" hospital in Turin between 2007 and 2015, with availability of full clinical data due to hospitalization at the same hospital contextually to the dosage or within ± 6 months. Exclusion criteria are specified in the appropriate section.
Criteria

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

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): NCT04495231


Locations
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Italy
Division of Endocrinology, Diabetology and Metabolism; University of Turin
Torino, Piemonte, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Mauro Maccario, MD Endocrinology, Diabetology and Metabolism; University of Turin
Study Chair: Ezio Ghigo, MD Endocrinology, Diabetology and Metabolism; University of Turin
Publications:

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Responsible Party: Mauro Maccario, Medical Doctor, Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT04495231    
Other Study ID Numbers: SympAct 1
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Mauro Maccario, University of Turin, Italy:
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
Additional relevant MeSH terms:
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Kidney Diseases
Hypertension
Heart Diseases
Essential Hypertension
Diabetes Mellitus
Metabolic Syndrome
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Insulin Resistance
Hyperinsulinism