Multicenter Study on Cardiovascular and Metabolic Complications in Patients With Biochemically Silent Pheochromocytomas and Paragangliomas

Обзор

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.

Подробное описание

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

Первичные конечные точки

• Changes in arterial blood pressure (BP) in mmHg before and after any therapeutic intervention [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline at diagnosis and 6 months post any intervention or follow-up]
• Incidence of cerebrovascular event permanent or transient [Срок оценки: Baseline at diagnosis and 6 months post any intervention or follow-up]
• Incidence of myocarditis before and after any therapeutic intervention [Срок оценки: Baseline at diagnosis and 6 months post any intervention or follow-up]

Вторичные конечные точки (2)

• Changes in the levels of blood Hb1Ac before and after any therapeutic intervention [Срок оценки: 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 [Срок оценки: Baseline at diagnosis and 6 months post any intervention or follow-up]

Критерии участия

Критерии включения

• All PHEOs/PGLs patients should be asymptomatic, with confirmed histopathological analysis for those who had surgery or with positive specific imaging functional studies (MIBG, 68Ga DOTATATE, Octreoscan, Tektrotyde)
• Data about the plasma or urine levels of catecholamines, normetanephrines, metanephrines and methoxytyramine (for PGL) levels should be available for every patient and should be lower than the upper normal values measured with LC-MS (supplementary data about CgA, NSE levels can be also included)
• Available data for the "required" cardiovascular paraclinical or metabolic parameters should be available pre-surgery or at the time of diagnosis or at follow-up for the "not operable" tumors as well as post any treatment

Критерии исключения

• Patients with ambiguous diagnosis of PHEOs/PGLs (absence of histological report and non-specific imaging findings)
• Catecholamines, normetanephrines and metanephrines (and methoxytyramine levels for PGL) levels higher than the upper limit range
• No available data of the required parameters

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Греция · 1 центр

• NKUA — Athens

Публикации

• 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. PMID 33882857
• 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. PMID 34957765
• 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. PMID 37522121
• 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. PMID 32751501
• 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. PMID 36325453

Идентификаторы

NCT: NCT07316075 · 2240/12.02.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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