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Enrolling by Invitation

NCT Number: NCT07316075

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

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.

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Key information

Conditions

Cardiovascular Abnormalities Angina Pectoris Angina, Unstable Arterial Blood Pressure Brain Diseases Cardiomyopathies Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disease Cerebrovascular Disorders Chest Pain Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Congestive Heart Failure Chronic Coronary Syndrome Diabete Mellitus Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Rate Hyperlipidaemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Myocarditis Myocarditis, Pericarditis Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nervous System Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Nutritional and Metabolic Diseases Pain Paraganglioma Pathological Conditions, Signs and Symptoms Pericarditis Pheochromocytoma Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NKUA

Athens, Greece

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Changes in arterial blood pressure (BP) in mmHg before and after any therapeutic intervention

    Time frame: Baseline at diagnosis and 6 months post any intervention or follow-up

    Mean Systolic and diastolic BP (x3) in mmHg before and after any therapeutic intervention or follow-up

  2. Changes in the heart rate (pulsation/min) before and after any therapeutic intervention or follow-up

    Time frame: Baseline at diagnosis and 6 months post any intervention or follow-up

    Mean heart rate before and after any therapeutic intervention or follow-up

  3. Changes in the fraction of ejection of the heart estimated by cardiac triplex before and after any treatment

    Time frame: Baseline at diagnosis and 6 months post any intervention or follow-up

    Echocardiogram and estimation of fraction of ejection before and after any treatment or follow-up

  4. Incidence (number) and characterisation of coronary syndrome (angina, cardiac infarction) before and after any intervention or follow-up

    Time frame: Baseline at diagnosis and 6 months post 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

  5. Incidence of cerebrovascular event permanent or transient

    Time frame: Baseline at diagnosis and 6 months post any intervention or follow-up

    Incidence of cerebrovascular disease, permanent or transient, and evaluation with cerebral MRI before and after any therapeutic intervention

  6. Incidence of myocarditis before and after any therapeutic intervention

    Time frame: Baseline at diagnosis and 6 months post any intervention or follow-up

    episode of myocarditis based on increased troponine, cardiac MRI and heart triplex before and after any intervention

Secondary outcomes

  1. Changes in the levels of blood Hb1Ac before and after any therapeutic intervention

    Time frame: Baseline at diagnosis and 6 months post any intervention or follow-up

    Measurement of Hb1AC % in the blood

  2. Changes in the concentrations of cholesterol, LDL and HDL in the blood before and after any intervention

    Time frame: 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

Other outcomes

  1. Changes of the Intima-Media Thickness and of Atheromatous Plaque before and after any intervention

    Time frame: Baseline at diagnosis and 6 months post any intervention or follow-up

    Triplex of carotides with measurement in mm of Intima-Media Thickness and of Atheromatous Plaque (appearance, surface)before and after any intervention

  2. Changes of proBNP levels in the blood before and after any intervention

    Time frame: Baseline at diagnosis and 6 months post any intervention or follow-up

    Mesurement of proBNP at blood analysis (pg/ml)

  3. Changes in troponine levels in the blood before and after any therapeutic intervention

    Time frame: Baseline at diagnosis and 6 months post any intervention or follow-up

    Measurement of troponine levels (ng/ml) in the blood

Sponsors and collaborators

Lead sponsor

Laikο General Hospital, Athens

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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