Sympathetic Activity and Cardiometabolic Complications (SYMPACT)

July 29, 2020 updated by: Mauro Maccario, University of Turin, Italy

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • Division of Endocrinology, Diabetology and Metabolism; University of Turin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline
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
At baseline
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
At baseline
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
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At baseline
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)
At baseline
Resting heart rate
Time Frame: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of resting heart rate (bpm)
At baseline
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)
At baseline
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)
At baseline
Fasting glucose
Time Frame: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of fasting glucose values (mg/dl)
At baseline
Total cholesterol
Time Frame: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of total cholesterol values (mg/dl)
At baseline
HDL cholesterol
Time Frame: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of HDL cholesterol values (mg/dl)
At baseline
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)
At baseline
Triglycerides
Time Frame: At baseline
The value of urinary metanephrines will be evaluated as a possible predictor of triglycerides values (mg/dl)
At baseline
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)
At baseline
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
At baseline
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
At baseline
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
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2007

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2020

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (ACTUAL)

July 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SympAct 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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