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The aim of the study is to characterise the cardiovascular and metabolic complications pre- and post-surgery of patients with biochemically negative PPGL and to compare them with normal individuals and patients with secreting PPGLs age and sex matched.
Pheochromocytomas (PHEO) and Paragangliomas (PGL) represent a group of tumors associated with increased cardiometabolic morbidities and mortality. The secretory components of PHEOs/PGLs are well-established risk factors for cardiovascular events and the Endocrine Society Clinical Practice Guidelines have implemented specific instructions for their management and their follow-up. However, data regarding the cardiovascular risk in PHEOs and PGLs asymptomatic patients with the normal biochemical profile are sparse and debating. The incidence of cardiovascular complications and the long-term morbidity in this group of patients is not well-characterized complicating the therapeutic approach or the necessity of pre-operative a-blockade as well as the optimal follow-up, regarding the duration and the need for cardiovascular examination.
Aim Primary outcome v To characterize the cardiovascular and metabolic complications of patients with biochemically negative PPGLs and to compare them with individuals age and sex-matched with normal adrenals (controls) as well as with patients with secreting PHEOs/PGLs.
Secondary outcome v To study also the sub-mentioned parameters post-treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with biochemically silent PPGLs | Patients with non-detectable levels of metanephrines/normetanephrines in the blood or in the urine via LC-MS. | ||
| Controls ( healthy individuals) | Healthy individuals with normal adrenal gland | ||
| Patients with secreting PPGLs | Patients with measurable levels of metanephrines or normetanephrines in the blood or urine ( > 2-fold) via LC-MS |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in arterial blood pressure (BP) in mmHg before and after any therapeutic intervention | Mean Systolic and diastolic BP (x3) in mmHg before and after any therapeutic intervention or follow-up | Baseline at diagnosis and 6 months post any intervention or follow-up |
| Changes in the heart rate (pulsation/min) before and after any therapeutic intervention or follow-up | Mean heart rate before and after any therapeutic intervention or follow-up | Baseline at diagnosis and 6 months post any intervention or follow-up |
| Changes in the fraction of ejection of the heart estimated by cardiac triplex before and after any treatment | Echocardiogram and estimation of fraction of ejection before and after any treatment or follow-up | Baseline at diagnosis and 6 months post any intervention or follow-up |
| Incidence (number) and characterisation of coronary syndrome (angina, cardiac infarction) before and after any intervention or follow-up | Incidence of an episode of coronary syndrome, like angina or cardiac infarction and evaluation of the electrocardiogram (changes of ST waves or Q waves or Left blovk branch) and signs of ventricule hypokinesia or akinesia in the heart triplex before and after any treatment or follow-up | Baseline at diagnosis and 6 months post any intervention or follow-up |
| Incidence of cerebrovascular event permanent or transient | Incidence of cerebrovascular disease, permanent or transient, and evaluation with cerebral MRI before and after any therapeutic intervention | Baseline at diagnosis and 6 months post any intervention or follow-up |
| Incidence of myocarditis before and after any therapeutic intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the levels of blood Hb1Ac before and after any therapeutic intervention | Measurement of Hb1AC % in the blood | Baseline at diagnosis and 6 months post any intervention or follow-up |
| Changes in the concentrations of cholesterol, LDL and HDL in the blood before and after any intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the Intima-Media Thickness and of Atheromatous Plaque before and after any intervention | Triplex of carotides with measurement in mm of Intima-Media Thickness and of Atheromatous Plaque (appearance, surface)before and after any intervention | Baseline at diagnosis and 6 months post any intervention or follow-up |
Inclusion Criteria:
Exclusion Criteria:
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Any adult patient with a confirmed histopathological or imaging diagnosis of PPGL (biochemical silent vs secreting)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NKUA | Athens | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33882857 | Background | Zhou J, Xuan H, Miao Y, Hu J, Dai Y. Acute cardiac complications and subclinical myocardial injuries associated with pheochromocytoma and paraganglioma. BMC Cardiovasc Disord. 2021 Apr 21;21(1):203. doi: 10.1186/s12872-021-02013-6. | |
| 34957765 | Background | Kumar A, Pappachan JM, Fernandez CJ. Catecholamine-induced cardiomyopathy: an endocrinologist's perspective. Rev Cardiovasc Med. 2021 Dec 22;22(4):1215-1228. doi: 10.31083/j.rcm2204130. |
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episode of myocarditis based on increased troponine, cardiac MRI and heart triplex before and after any intervention |
| Baseline at diagnosis and 6 months post any intervention or follow-up |
Measurement of blood cholesterol in mg/dl, HDL in mg/dl and LDL in mg/dl before and after any therapeutic intervention |
| Baseline at diagnosis and 6 months post any intervention or follow-up |
| Changes of proBNP levels in the blood before and after any intervention |
Mesurement of proBNP at blood analysis (pg/ml) |
| Baseline at diagnosis and 6 months post any intervention or follow-up |
| Changes in troponine levels in the blood before and after any therapeutic intervention | Measurement of troponine levels (ng/ml) in the blood | Baseline at diagnosis and 6 months post any intervention or follow-up |
| 37522121 | Background | Szatko A, Glinicki P, Gietka-Czernel M. Pheochromocytoma/paraganglioma-associated cardiomyopathy. Front Endocrinol (Lausanne). 2023 Jul 13;14:1204851. doi: 10.3389/fendo.2023.1204851. eCollection 2023. |
| 32751501 | Background | Y-Hassan S, Falhammar H. Cardiovascular Manifestations and Complications of Pheochromocytomas and Paragangliomas. J Clin Med. 2020 Jul 30;9(8):2435. doi: 10.3390/jcm9082435. |
| 36325453 | Background | Constantinescu G, Preda C, Constantinescu V, Siepmann T, Bornstein SR, Lenders JWM, Eisenhofer G, Pamporaki C. Silent pheochromocytoma and paraganglioma: Systematic review and proposed definitions for standardized terminology. Front Endocrinol (Lausanne). 2022 Oct 17;13:1021420. doi: 10.3389/fendo.2022.1021420. eCollection 2022. |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D000789 | Angina, Unstable |
| D002561 | Cerebrovascular Disorders |
| D009205 | Myocarditis |
| D010493 | Pericarditis |
| D006949 | Hyperlipidemias |
| D003920 | Diabetes Mellitus |
| D010673 | Pheochromocytoma |
| D010235 | Paraganglioma |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009202 | Cardiomyopathies |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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