Diabetes Mellitus, Type 2 Clinical Trial
— SYMPACTOfficial title:
Association Between Enhanced Sympathetic Activity and Cardiometabolic Complications: a Cross-sectional Study on Predictive Power of 24-hour Urinary Metanephrines (SYMPACT)
NCT number | NCT04495231 |
Other study ID # | SympAct 1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2007 |
Est. completion date | July 1, 2020 |
Verified date | July 2020 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1380 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Division of Endocrinology, Diabetology and Metabolism; University of Turin | Torino | Piemonte |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Brown MJ, Causon RC, Barnes VF, Brennan P, Barnes G, Greenberg G. Urinary catecholamines in essential hypertension: results of 24-hour urine catecholamine analyses from patients in the Medical Research Council trial for mild hypertension and from matched controls. Q J Med. 1985 Oct;57(222):637-51. — View Citation
Coulson JM. The relationship between blood pressure variability and catecholamine metabolites: a pilot study. J Hum Hypertens. 2015 Jan;29(1):50-2. doi: 10.1038/jhh.2014.23. Epub 2014 Apr 3. — View Citation
Dudenbostel T, Acelajado MC, Pisoni R, Li P, Oparil S, Calhoun DA. Refractory Hypertension: Evidence of Heightened Sympathetic Activity as a Cause of Antihypertensive Treatment Failure. Hypertension. 2015 Jul;66(1):126-33. doi: 10.1161/HYPERTENSIONAHA.115.05449. Epub 2015 May 18. — View Citation
Eisenhofer G, Friberg P, Pacak K, Goldstein DS, Murphy DL, Tsigos C, Quyyumi AA, Brunner HG, Lenders JW. Plasma metadrenalines: do they provide useful information about sympatho-adrenal function and catecholamine metabolism? Clin Sci (Lond). 1995 May;88(5):533-42. — View Citation
Eisenhofer G, Kopin IJ, Goldstein DS. Catecholamine metabolism: a contemporary view with implications for physiology and medicine. Pharmacol Rev. 2004 Sep;56(3):331-49. Review. — View Citation
Esler M, Lambert G, Jennings G. Increased regional sympathetic nervous activity in human hypertension: causes and consequences. J Hypertens Suppl. 1990 Dec;8(7):S53-7. Review. — View Citation
Esler M. The sympathetic nervous system in hypertension: back to the future? Curr Hypertens Rep. 2015 Feb;17(2):11. doi: 10.1007/s11906-014-0519-8. Review. — View Citation
Flaa A, Aksnes TA, Kjeldsen SE, Eide I, Rostrup M. Increased sympathetic reactivity may predict insulin resistance: an 18-year follow-up study. Metabolism. 2008 Oct;57(10):1422-7. doi: 10.1016/j.metabol.2008.05.012. — View Citation
Goldstein DS, Eisenhofer G, Kopin IJ. Sources and significance of plasma levels of catechols and their metabolites in humans. J Pharmacol Exp Ther. 2003 Jun;305(3):800-11. Epub 2003 Mar 20. Review. — View Citation
Grassi G, Mark A, Esler M. The sympathetic nervous system alterations in human hypertension. Circ Res. 2015 Mar 13;116(6):976-90. doi: 10.1161/CIRCRESAHA.116.303604. Review. — View Citation
Lenders JW, Duh QY, Eisenhofer G, Gimenez-Roqueplo AP, Grebe SK, Murad MH, Naruse M, Pacak K, Young WF Jr; Endocrine Society. Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Jun;99(6):1915-42. doi: 10.1210/jc.2014-1498. — View Citation
Mancia G, Bousquet P, Elghozi JL, Esler M, Grassi G, Julius S, Reid J, Van Zwieten PA. The sympathetic nervous system and the metabolic syndrome. J Hypertens. 2007 May;25(5):909-20. Review. — View Citation
Masuo K, Kawaguchi H, Mikami H, Ogihara T, Tuck ML. Serum uric acid and plasma norepinephrine concentrations predict subsequent weight gain and blood pressure elevation. Hypertension. 2003 Oct;42(4):474-80. Epub 2003 Sep 2. — View Citation
Masuo K, Mikami H, Ogihara T, Tuck ML. Sympathetic nerve hyperactivity precedes hyperinsulinemia and blood pressure elevation in a young, nonobese Japanese population. Am J Hypertens. 1997 Jan;10(1):77-83. — View Citation
Okuyama Y, Sakata Y. [Device treatment approaches targeting the sympathetic nervous system in patients with resistant hypertension]. Nihon Rinsho. 2015 Nov;73(11):1857-63. Japanese. — View Citation
Quarti Trevano F, Dell'Oro R, Biffi A, Seravalle G, Corrao G, Mancia G, Grassi G. Sympathetic overdrive in the metabolic syndrome: meta-analysis of published studies. J Hypertens. 2020 Apr;38(4):565-572. doi: 10.1097/HJH.0000000000002288. — View Citation
Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlöf B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X. — View Citation
Schlaich MP, Kaye DM, Lambert E, Sommerville M, Socratous F, Esler MD. Relation between cardiac sympathetic activity and hypertensive left ventricular hypertrophy. Circulation. 2003 Aug 5;108(5):560-5. Epub 2003 Jul 7. — View Citation
Straznicky NE, Grima MT, Sari CI, Karapanagiotidis S, Wong C, Eikelis N, Richards KL, Lee G, Nestel PJ, Dixon JB, Lambert GW, Schlaich MP, Lambert EA. The relation of glucose metabolism to left ventricular mass and function and sympathetic nervous system activity in obese subjects with metabolic syndrome. J Clin Endocrinol Metab. 2013 Feb;98(2):E227-37. doi: 10.1210/jc.2012-3277. Epub 2012 Dec 27. — View Citation
Tank AW, Lee Wong D. Peripheral and central effects of circulating catecholamines. Compr Physiol. 2015 Jan;5(1):1-15. doi: 10.1002/cphy.c140007. Review. — View Citation
Ton QV, Hammes SR. Recent insights on circulating catecholamines in hypertension. Curr Hypertens Rep. 2014 Dec;16(12):498. doi: 10.1007/s11906-014-0498-9. Review. — View Citation
Wang W, Mu L, Su T, Ye L, Jiang Y, Jiang L, Zhou W. Plasma Metanephrines Are Associated With Glucose Metabolism in Patients With Essential Hypertension. Medicine (Baltimore). 2015 Sep;94(37):e1496. doi: 10.1097/MD.0000000000001496. — View Citation
Zhou Y, Yuan J, Wang Y, Qiao S. Plasma metanephrins are associated with myocardial hypertrophy and cardiac diastolic function in patients with essential hypertension. Clin Invest Med. 2020 Apr 5;43(1):E22-E29. doi: 10.25011/cim.v43i1.33581. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of left ventricular hypertrophy | The value of urinary metanephrines will be evaluated as a possible predictor of the presence of left ventricular hypertrophy | At baseline | |
Primary | Presence of chronic kidney disease | The value of urinary metanephrines will be evaluated as a possible predictor of the presence of chronic kidney disease | At baseline | |
Primary | Presence of type 2 diabetes mellitus | The value of urinary metanephrines will be evaluated as a possible predictor of the presence of type 2 diabetes mellitus | At baseline | |
Primary | Presence of metabolic syndrome | The value of urinary metanephrines will be evaluated as a possible predictor of the presence of metabolic syndrome | At baseline | |
Secondary | Systolic blood pressure (SBP) | The value of urinary metanephrines will be evaluated as a possible predictor of systolic blood pressure values (mmHg) | At baseline | |
Secondary | Diastolic blood pressure (DBP) | The value of urinary metanephrines will be evaluated as a possible predictor of diastolic blood pressure values (mmHg) | At baseline | |
Secondary | Resting heart rate | The value of urinary metanephrines will be evaluated as a possible predictor of resting heart rate (bpm) | At baseline | |
Secondary | eGFR | 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 | |
Secondary | Urinary albumin/creatinine ratio | The value of urinary metanephrines will be evaluated as a possible predictor of albumin/creatinine ratio values (mg/mmol) | At baseline | |
Secondary | Fasting glucose | The value of urinary metanephrines will be evaluated as a possible predictor of fasting glucose values (mg/dl) | At baseline | |
Secondary | Total cholesterol | The value of urinary metanephrines will be evaluated as a possible predictor of total cholesterol values (mg/dl) | At baseline | |
Secondary | HDL cholesterol | The value of urinary metanephrines will be evaluated as a possible predictor of HDL cholesterol values (mg/dl) | At baseline | |
Secondary | LDL cholesterol | 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 | |
Secondary | Triglycerides | The value of urinary metanephrines will be evaluated as a possible predictor of triglycerides values (mg/dl) | At baseline | |
Secondary | Body Mass Index (BMI) | The value of urinary metanephrines will be evaluated as a possible predictor of BMI values (kg/m2) | At baseline | |
Secondary | Cardiovascular risk as estimated by Framingham Risk Score (FRS) | 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 | |
Secondary | Cardiovascular risk as estimated by Systematic COronary Risk Evaluation (SCORE) | 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 | |
Secondary | Cardiovascular risk as estimated by Progetto Cuore Score (english translation: "Heart Project Score") | 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 |
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